bmj open · burlo garofolo, via dell’istria 65/1, 34137 trieste, italy (adriano cattaneo, anna...

For peer review only

The effectiveness of the Baby Friendly Community Initiative

in Italy: a non-randomised controlled study

Journal: BMJ Open

Manuscript ID bmjopen-2015-010232

Article Type: Research

Date Submitted by the Author: 09-Oct-2015

Complete List of Authors: Cattaneo, Adriano; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Bettinelli, Maria; Local Health Authority, Maternal and Child Health Unit, Department of Primary Care Chapin, Elise; Italian Committee for UNICEF, Baby Friendly Initiatives Macaluso, Anna; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Córdova do Espírito Santo, Lílian; National Council for Technological and Scientific Development Murante, Anna Maria; Scuola Superiore Sant'Anna, Istituto di MAnagement - Laboratorio Management e sanità Montico, Marcella; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Epidemiology and Biostatistics

<b>Primary Subject Heading</b>:

Health services research

Secondary Subject Heading: Paediatrics

Keywords: Breastfeeding, Baby-Friendly Initiatives, Italy

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The effectiveness of the Baby Friendly Community Initiative in Italy: a non-randomised controlled

study

Running title: Baby-Friendly Community Initiative

Adriano Cattaneo, Maria Enrica Bettinelli, Elise Chapin, Anna Macaluso, Lílian Córdova do

Espírito Santo, Anna Maria Murante, Marcella Montico, on behalf of the BFCI Study Group

Health Services Research and International Health, Institute for Maternal and Child Health IRCCS

Burlo Garofolo, Via dell’Istria 65/1, 34137 Trieste, Italy (Adriano Cattaneo, Anna Macaluso),

Maternal and Child Health Unit, Department of Primary Care, Local Health Authority, 20122

Milan, Italy (Maria Enrica Bettinelli), Baby Friendly Initiatives, Italian Committee for UNICEF,

00185 Rome, Italy (Elise M. Chapin), Grant recipient, National Council for Technological and

Scientific Development, Porto Alegre, Brazil (Lílian Córdova do Espírito Santo), Management and

Health Laboratory, Institute of Management, Scuola Superiore Sant’Anna, 56127 Pisa, Italy (Anna

Maria Murante), Epidemiology and Biostatistics, Institute for Maternal and Child Health IRCCS

Burlo Garofolo, 34137 Trieste, Italy (Marcella Montico).

Correspondence to: [email protected]; mobile +393206797647

Keywords: breastfeeding, Baby Friendly Initiatives, Italy

Word count (text): 4389

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Abstract

Objective. To assess the effectiveness of the Baby Friendly Community Initiative (BFCI) on

exclusive breastfeeding to six months.

Design. Controlled, non-randomised trial.

Setting. 18 Local Health Authorities in 9 regions of Italy.

Participants. 5094 mother/infant dyads in three cohorts followed-up to 12 months after birth in three

rounds of data collection: at baseline, after implementation of the intervention in the early

intervention group, and after implementation in the late intervention group. 689 (14%) dyads did

not complete the study.

Intervention. Implementation of the 7 Steps of the BFCI.

Main outcome measures. The rate of exclusive breastfeeding at 6 months was the primary outcome;

breastfeeding at discharge, 3 and 12 months were also measured.

Results. The crude rates of exclusive breastfeeding at discharge, 3 and 6 months, and of any

breastfeeding at 6 and 12 months increased at each round of data collection after baseline in both

the early and late intervention groups. At the end of the project, 10% of infants were exclusively

breastfed at 6 months and 38% were continuing to breastfeed at 12 months. However, the

comparison by adjusted rates and logistic regression failed to show statistically significant

differences between groups and rounds of data collection in the intention-to-treat analysis, but also

when compliance with the intervention and training coverage were taken into account.

Conclusions. The study failed to demonstrate an effect of the BFCI on the rates of breastfeeding.

This may be due to, among other factors, to the time needed to observe an effect on breastfeeding

following this complex intervention.

Word count: 254

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Strengths and limitations of this study

• Implementation of a complex multisectoral intervention for the protection, promotion and

support of breastfeeding, with synergistic engagement of many different actors.

• Controlled, non-randomised trial with possible effect measured in three rounds of data

collection, before and after a phased implementation of the intervention.

• Rates of breastfeeding compared between groups of local health authorities by intention to

treat, compliance with the intervention and training coverage.

• Rates of breastfeeding increased during the four years of the study, but this may not have had

the power to identify small differences as significant.

• The effects of a complex intervention such as the Baby Friendly Community Initiative may

need more than the four years of the study to be observed.

What is already known on this subject

• The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that

contributes to increasing the initiation, exclusivity and duration of breastfeeding.

• The BFHI alone, however, does not help achieve exclusive breastfeeding to six months and

continuation, with adequate complementary foods, up to two years and beyond.

• Interventions at the community level are needed to improve breastfeeding exclusivity to six

months and continuation well into the second year of life.

What this study adds

• An intervention based on the Baby Friendly Community Initiative (BFCI) failed to

demonstrate an effect on the rates of breastfeeding up to 12 months.

• This may be due, among other factors, to the time needed to observe an effect, probably

longer than the duration of this study.

• This study did not allow to determine that the BFCI is effective, but paved the way for better

practices in the study and other areas.

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Introduction

The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that

contributes to increasing the initiation, exclusivity and duration of breastfeeding.1,2 Alone, however,

it cannot achieve the goals recommended by WHO, UNICEF and many national and professional

policies, i.e. exclusive breastfeeding (EBF) for six months and continued breastfeeding, with

adequate complementary foods, up to two years and beyond.3-6 Worldwide, rates of EBF to 6

months fall short of those recommended;7-9 interventions at the community level, in addition to the

hospital-based ones, are needed to improve them.10 Several community interventions, such as

primary-care-based educational programmes,11,12 competent professional support at home or in

health facilities,13 home visits by trained professionals,

14 home-based peer counselling,

15 or the

involvement of fathers,16,17 have been shown to be effective. In some countries, these interventions

have been integrated into Baby Friendly Community Initiatives (BFCI),18-20 generally considered as

an appropriate framework.21

The Italian Committee for UNICEF, which promotes and coordinates the BFHI in Italy, established

a working group to adapt and develop the BFCI for the national health system, in collaboration with

the Local Health Authority (LHA) of Milan, where it was initially piloted and later launched in

2007. The BFCI is based on the Seven Point Plan used in the UK and ew Zealand, and includes

tools for planning, implementation, monitoring and evaluation described in a companion paper.22

Briefly, the 7 Steps of the BFCI (Table 1) are supposed to be implemented in all the non-hospital-

based health facilities of a LHA. These include health centres, mother and child health clinics,

family health centres, public and private medical, obstetric and paediatric practices, day care

centres, and, where present, public pharmacies. All the health and social workers of these facilities

have to be trained, in courses of different duration, to implement a policy previously developed by a

multidisciplinary team and approved by the LHA management. Health professionals are trained to

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help breastfeeding as well as formula-feeding mothers when and where they ask for support.

Moreover, the LHA is required to create breastfeeding-friendly environments not only in its

premises and facilities, but also in other community and public places, such as workplaces and

shops, environments where nursing mothers feel welcome and breastfeeding is considered a natural

act that can be done in public. Health and social centres are encouraged to collaborate with other

services and groups that offer support for infant feeding, including mother-to-mother and peer

support groups that are not part of the health care system. Finally, the LHA is required to abide by

the International Code of Marketing of Breast-Milk Substitutes.

Table 1. The Seven Steps of the Baby Friendly Community Initiative

1. Have a written breastfeeding policy that is routinely communicated to all staff.

2. Train all staff to implement the breastfeeding policy.

3. Inform all pregnant women and their families about the benefits and management of

breastfeeding.

4. Support mothers to initiate and sustain breastfeeding.

5. Encourage exclusive breastfeeding up to 6 months of age, the introduction of appropriate

complementary foods after 6 months, and continued breastfeeding.

6. Provide a welcoming atmosphere for breastfeeding families.

7. Promote cooperation between health care staff, breastfeeding support groups, and the local

community.

In 2009, 18 LHAs, which had expressed an interest in the BFCI, accepted the invitation from the

Italian Committee for UNICEF of working towards BFCI accreditation. This was an opportunity to

set up a research project to look at the effectiveness of the BFCI in terms of rates and duration of

EBF to six months, a recognized research priority.23 The methods and some baseline data of this

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project have already been reported in a second companion paper.24 This third paper reports the final

results.

Methods

The methods of this research project have already been described.24 Briefly, this non-randomised

controlled trial involved 18 LHAs in 9 regions of northern and central Italy. The study design

(Figure 1) demanded that 9 LHAs started implementing the 7 Steps after baseline data collection

(early intervention group), while the remaining 9 would start about 12 months later, after a second

round of data collection (late intervention group); a third round of data collection would be carried

out about 12 months after implementing the intervention in the latter group. Some LHAs, however,

had already started implementing BFCI activities before the study was designed: Milan because it

had a leading role in developing the materials and tools and pilot testing them; others because they

had been part of the working group that adapted the BFCI for Italy, or had previously worked on

developing draft policies, or had conducted some limited staff training, especially where there was a

Baby Friendly Hospital (BFH). For these reasons, it was impossible to randomize the 18 LHAs into

early and late intervention groups. They were instead paired based on the reported rate of EBF at

around 5 months of age, on their population, and on their setting and population density (i.e.

whether the LHA was mostly urban or rural). Within each pair, LHAs were then assigned to the

early or late intervention groups based on whether they had already implemented some activity or

not.

The rate of EBF at 6 months was the primary outcome of the study. To compare these rates between

groups and within them over time, data were gathered in three rounds. At each round of data

collection, starting in the fall of 2009, cohorts of infants were followed from birth to 12 months,

with interviews at discharge and at 3, 6 and 12 months, in each of the three rounds. Mothers were

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recruited consecutively in the hospitals serving the 18 LHAs, until the intended sample size was

attained. After obtaining informed consent, the first interview with the mother was conducted face-

to-face just before discharge using a 36-item questionnaire that included three questions on feeding

both within the previous 24 hours and from birth (Has the baby had breastmilk? Has the baby had

formula? Has the baby had other fluids, and if so what?), questions on potential confounders, as

well as basic information used to identify the subject. If, for any reason, it was impossible to

interview the mother during hospital stay, the interview was carried out by telephone within one

week of giving birth; this occurred with 212 (12%) mothers. These interviews were performed by

the staff in charge of the BFCI in each LHA. The interviews at 3, 6 and 12 months included five

yes/no questions on foods and fluids taken in the previous 24 hours (breastmilk, formula, animal

milks, non-nutritive fluids, and solids or semisolids), plus an additional question for infants fed only

breastmilk on other foods and fluids taken in the previous 7 days, to compensate for the well-known

overestimate of EBF using a 24-hour recall.25,26 These questions, complemented in the interview at

12 months by questions on breastfeeding problems and ways they were solved or not, were

administered by researchers of the Management and Health Laboratory at Scuola Superiore

Sant’Anna, Pisa, specialized in conducting surveys using Computer-Assisted Telephone

Interviewing (CATI) methods. These interviewers were unaware of the assignment to the early or

late intervention groups. The different categories of feeding were automatically derived from the

different combinations of answers.27,28 All infants were followed up to 12 months of age

irrespective of their feeding status. The interviews at 12 months in the third round of data collection

were concluded in March of 2012.

The sample size for each cohort was established on the assumption that the BFCI could result in a

10% increase in the rate of EBF at 6 months, from the baseline 25% estimate, as a weighted and

adjusted average of the range from 10% to 60% reported for 2007 or 2008 by the 18 LHAs at

around 5 months of age. These reports were based on data gathered most often at immunization or,

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less often, during small cross-sectional or longitudinal surveys, with questionnaires, definitions of

feeding categories and recall periods that were not standardized, and on samples that might have not

represented the population. Based on the above assumption, the sample size for a controlled trial

with a precision of 5% and a power of 80% would amount to 348 subjects per study arm. Due to the

cluster design of the study, this number was doubled to 1392 subjects, 696 per study arm,

considering a possible and conservative design effect of 2. The final sample size of 1740 mother-

infant pairs per round of data collection takes into account a possible 20% loss to follow up. This

sample size was then distributed among the 18 LHAs in proportion to their estimated number of

annual births. Exclusion criteria were a birth weight lower than 2000 g, any post-partum condition

that required admission into a neonatal intensive care unit, the practical impossibility of conducting

the interview (mother or relative unable to understand Italian, English, French or Spanish), and

residence outside the area covered by the LHA. Twins were recruited as separate subjects. As

described in the first companion paper,22 data collection included a self-assessment questionnaire

completed by the 18 LHAs on the progress made in implementing the 7 Steps, each step having a

set of 3 to 11 criteria based on the same model used for the self-assessment of the BFHI.29 In

addition, each LHA was supposed to develop annual action plans and to report on the degree of

implementation.

After a phase of planning and pilot testing of the tools,22 baseline data collection started in

September 2009 and was successfully completed; the second and third rounds were completed as

planned. Data from face-to-face interviews were manually inputted into customized EpiData Files,

and later exported to MS Excel, by the research assistants in each of the 18 sites. Those from the

CATI system (at 3, 6 and 12 months) were recorded answer-by-answer in real time and

automatically saved into a separate relational database, one for each round of data collection, and

were then extracted to MS Excel files. Finally, all the data from each round were integrated into a

single MS Excel file in Trieste, using the individual ID codes for record linkage. Data were then

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checked for completeness, consistency and accuracy, and research assistants at the 18 sites were

notified of possible mistakes for correction after comparison with the original paper records. Data

analysis was carried out using Stata 13. Differences in baseline characteristics were analysed with

Chi squared test or t-test as appropriate. Differences in rates of breastfeeding between early and late

intervention groups at different time points were assessed with logistic regression models using a

backward stepwise selection approach that retained only the variables associated with breastfeeding

at the 0.05 level of significance and took into account the effect of the cluster design (cluster

command in Stata 13). The tested variables were: maternal age, nationality, education, paid

occupation, living with a partner, smoking before and during pregnancy, maternal pre-pregnancy

BMI, gestational diabetes, parity, twin pregnancy, attending an antenatal course, birth in a BFH,

type of delivery, analgesia or anaesthesia in labour, intention to breastfeed, gestational age, birth

weight, timing of the first breastfeed, rooming-in, baby-led feeding, use of bottle and/or pacifier

during hospital stay. The results of the logistic regression models were used to obtain adjusted

breastfeeding rates at different ages, with 95% confidence intervals adjusted for the effect of the

cluster design.

Results

Table A1 in appendix shows the number of subjects enrolled and followed up to 12 months by LHA

in the early and late intervention groups and by round of data collection. The final database includes

5094 records of enrolled mother-baby dyads, including 107 twins (2%), 126 dyads less than the

intended overall sample size due to the failure of two LHAs, both in the late intervention group, to

participate in one of the data collection rounds. For the analysis at three months, 4704 dyads are

available, a loss of 7.7%; at six months, data are available on 4572 dyads, a further 2.8% loss; at 12

months, 4405 dyads completed the series of interviews, for a total loss to follow up of 13.5% (range

of 9% to 20% among LHAs, no significant differences by intervention group and by round of data

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collection), less than the 20% predicted when the sample size was calculated. A total of 281 eligible

mothers declined to be enrolled for various reasons; there were no significant differences between

participant and non-participant mothers except for nationality, the proportion of foreign women

being higher among the latter. Table 2 shows the characteristics of the mothers and infants included

in the analysis, by study group. The demographic characteristics of the sample were similar to

national averages in terms of age and education, while the percentage of women with a paid

employment was slightly higher.30 More women in the sample attended antenatal classes than do on

average throughout the country (44% vs. 35%).31 It is also worth noting that the rate of caesarean

delivery (27-29%) was well below the national average of 38%, although slightly fewer women had

term births (90-92% vs. 93%). There were several statistically significant differences between early

and late intervention groups; these differences were accounted for in the multivariate analysis. The

significantly better perinatal care practices reported by mothers in the early intervention group are

probably due to the higher percentage of births in BFHs.

Table 2. Characteristics of the mothers and infants included in the analysis, by study group.

Early intervention Late intervention p-value

Mean (sd) age (years) 32 (5) 32 (5) 0.121

Mean (sd) education (years) 14 (4) 13 (4) <0.001

Employment: paid occupation 76% 78% 0.095

Italian 85% 85% 0.535

Living with the partner 97% 96% 0.004

Smoking before pregnancy 29% 27% 0.109

during pregnancy 11% 8% 0.003

Referred BMI <25 80% 79% 0.436

25-29.9 14% 15%

>=30 6% 6%

Gestational diabetes 7% 8% 0.021

Primiparae 57% 54% 0.053

Attendance to antenatal classes 44% 44% 0.716

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At least one session on BF 82% 87% 0.002

Delivery at term (38-41 weeks) 92% 90% 0.003

Caesarean section rate 27% 29% 0.058

Anaesthesia or analgesia during

labour/delivery (including C-section)

55% 60% <0.001

Mean (sd) birth weight (g) 3304 (443) 3283 (443) 0.092

Previous breastfeeding experience 41% 44% 0.126

Of which <6 months 31% 37% 0.034

6-12 months 45% 42%

13-24 months 20% 18%

>24 months 4% 3%

Intention to breastfeed current baby 99% 98% 0.126

exclusively for at least 6 m 82% 80% 0.184

Birth in a Baby Friendly Hospital 32% 27% <0.001

Baby latched on within 1 hour 61% 67% <0.001

Rooming-in (24h/day, all infants) 77% 80% 0.080

Baby-led BF (breastfed infants) 90% 89% 0.246

Baby used bottle (all infants) 20% 18% 0.001

Baby used pacifier (all infants) 19% 26% <0.001

Figures 2-6 show the crude rates of EBF at discharge (recall from birth) and at three and six months

(recall 7 days), and the crude rates of any breastfeeding at six and 12 months (recall 24 hours). By

the end of the project, almost 70% of infants were exclusively breastfed at discharge, with an

increasing trend between rounds 1 and 3 of data collection, and with great variation among sites

(range: 26% to 93%). Both the upward trend between the first and the third round of data collection,

and the variation among sites, are present at 3, 6 and 12 months, for both exclusive and any

breastfeeding. At the third round of data collection, the rates of EBF were fairly high at three

months (54% at round 3, range 36% to 66%), but dropped to 8% (range 1% to 23%) at six months.

These rates were lower than expected, even when considering the figures for the 24-hour recall:

10% (range 3% to 23%). At the end of the project, almost 38% of infants were continuing to

breastfeed at 12 months.

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Crude rates, however, cannot be used for comparisons, as this was not a randomised trial and

confounding has to be considered. Table 3 shows the adjusted rates of exclusive and any

breastfeeding at different ages and with different recall periods by intervention group and round of

data collection. Though there was a clear pattern of higher rates in the early intervention group,

there were no statistically significant differences between groups and rounds of data collection as

far as adjusted rates at discharge (not shown) are concerned. The lack of a statistically significant

difference between groups had already been noted at baseline,24 when it was in fact expected

because sites were paired by breastfeeding rates, and persisted through the second and third round

of data collection. Table 3 shows an upward trend of the adjusted rates of breastfeeding between

rounds of data collection, with the exception of EBF and ABF at six months in the early

intervention group. Yet none of the differences between and within groups is statistically

significant. The removal of twins from the dataset did not change the results.

Table 3. Adjusted rates (%) of exclusive (EBF) and any (ABF) breastfeeding at different ages and

with different recall periods by intervention group and round of data collection.

Breastfeeding

indicators

Early intervention group Late intervention group

Round n % (95% CI) n % (95% CI)

EBF at 3 m

(recall 24 h)

1 852 58.1 (52.1 – 64.1) 746 52.8 (47.3 – 58.4)

2 845 57.5 (54.4 – 60.7) 645 53.6 (45.7 – 61.6)

3 867 62.3 (59.8 – 64.7) 633 57.9 (53.8 – 62.1)

EBF at 3 m

(recall 7 d)

1 852 49.6 (43.5 – 55.7) 746 43.4 (38.3 – 48.5)

2 845 52.9 (48.7 – 57.2) 645 50.0 (41.5 – 58.4)

3 867 55.9 (52.3 – 59.4) 633 51.1 (47.5 – 54.6)

EBF at 6 m

(recall 24 h)

1 822 9.0 (6.2 – 11.9) 726 7.1 (3.9 – 10.2)

2 835 7.7 (5.4 – 9.9) 636 8.4 (4.7 – 12.2)

3 842 7.6 (4.9 – 10.3) 599 9.6 (7.2 – 12.1)

EBF at 6 m 1 822 5.5 (3.8 – 7.2) 726 5.3 (2.8 – 7.7)

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(recall 7 d) 2 835 5.6 (3.7 – 7.4) 636 6.7 (3.7 – 9.8)

3 842 5.4 (2.7 – 8.0) 599 7.6 (5.6 – 9.6)

ABF at 6 m

(recall 24 h)

1 822 67.6 (62.5 – 72.7) 726 62.4 (55.8 – 69.0)

2 835 66.7 (63.5 – 69.9) 636 63.4 (59.4 – 67.3)

3 842 69.0 (66.2 – 71.8) 599 65.4 (61.4 – 69.5)

ABF at 12 m

(recall 24 h)

1 777 32.4 (26.6 – 38.2) 683 28.6 (24.1 – 33.2)

2 820 34.9 (32.4 – 37.5) 611 30.8 (24.0 – 37.6)

3 817 36.2 (32.4 – 40.1) 592 34.9 (30.9 – 39.0)

As the periodic self-assessments had revealed that some of the study sites were making progress in

the implementation of the 7 Steps, while others were lagging behind, we carried out a comparison

by compliance with the intervention, in addition to the analysis by intention to treat. Table 4 shows

the same adjusted rates of breastfeeding of Table 3 after re-grouping the 18 LHAs by compliance

with the intervention. This comparison shows some statistically significant differences between

groups (EBF at three months in rounds 1 and 3, and ABF at six months in rounds 2 and 3) and

between rounds (EBF at three months between rounds 1 and 3 in the non-compliance group), but it

does not show an effect of the intervention. We repeated the same statistical analysis using staff

training to re-group the 18 LHAs into groups with higher and lower training coverage; results (not

shown but available on request) and interpretation did not change. It is interesting to note, however,

that, despite the apparent lack of effect of the intervention and despite similar adjusted rates of

initiation (between 65% and 72% in both groups), the LHAs in the compliance and higher training

coverage groups presented consistently higher rates of breastfeeding throughout the first year of

life. Once again, the removal of twins did not change the results.


with different recall periods by compliance with the intervention and round of data collection.

Breastfeeding Compliance group Non-compliance group

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indicators Round n % (95% CI) n % (95% CI)

EBF at 3 m

(recall 24 h)

1 978 60.6 (56.2 – 65.0)§ 620 47.6 (43.6 – 51.6)§*

2 979 58.4 (54.9 – 61.9) 511 51.0 (42.8 – 59.1)

3 993 63.5 (61.4 – 65.7)§ 507 54.5 (51.7 – 57.3)§*

EBF at 3 m

(recall 7 d)

1 978 51.1 (46.1 – 56.1)§ 620 39.7 (35.6 – 43.8)§*

2 979 53.9 (49.6 – 58.3) 511 47.3 (38.7 – 55.9)

3 993 56.8 (53.7 – 59.9)§ 507 48.1 (45.1 – 51.2)§*

EBF at 6 m

(recall 24 h)

1 947 9.8 (7.0 – 12.6) 601 5.6 (2.5 – 8.7)

2 956 8.3 (5.5 – 11.1) 515 7.5 (4.1 – 10.9)

3 951 9.4 (6.8 – 12.1) 490 6.5 (3.5 – 9.5)

EBF at 6 m

(recall 7 d)

1 947 6.3 (4.6 – 7.9) 601 4.2 (1.7 – 6.8)

2 956 6.4 (4.0 – 8.8) 515 5.6 (3.1 – 8.1)

3 951 7.0 (4.1 – 9.9) 490 4.7 (2.6 – 6.8)

ABF at 6 m

(recall 24 h)

1 947 68.9 (64.4 – 73.3) 601 59.1 (53.2 – 65.0)

2 956 67.4 (65.2 – 69.6)§ 515 61.1 (57.3 – 65.0)§

3 951 70.3 (67.6 – 73.1)§ 490 62.1 (59.6 – 64.6)§

ABF at 12 m

(recall 24 h)

1 890 33.5 (28.5 – 38.5) 570 26.2 (21.7 – 30.7)

2 931 35.3 (32.2 – 38.4) 500 29.3 (22.3 – 36.3)

3 930 37.6 (34.3 – 40.9) 479 32.1 (28.0 – 36.1)

§ p<0.05 between groups; * p<0.05 between rounds.

We carried out also a logistic regression analysis including all the variables used to adjust the rates

of breastfeeding, plus the rates of EBF at discharge (recall from birth). Tables A2 and A3 in

appendix show the adjusted rates of breastfeeding and the odd ratios, with their respective 95%

confidence intervals, by early and late intervention and by compliance and non-compliance,

respectively, and by round of data collection, using the rates of the late intervention and non-

compliance groups at round 1 as comparators. Using this logistic regression model, a small number

of odd ratios result in statistically significant differences. These differences, however, do not

indicate a clear association between the BFCI intervention, or compliance with it, and increased

rates of breastfeeding.

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Finally, we analysed the answers mothers gave at the 12-month interview when asked if they had

had problems with breastfeeding, where they had looked for help, and whether they thought that

those providing help had solved their problems or not. Overall, the 5094 mothers reported 1082

problems, mainly breast and nipple complaints (39%), not enough milk (32%) and difficulties

latching the baby on (20%), with no statistically significant differences between groups and rounds

of data collection. There were no differences also in the percentage of mothers who sought help for

these problems either. Some relevant statistically significant differences (p<0.05) were found when

mothers were asked to evaluate on a Likert scale the help received by level of usefulness in solving

their problems. Mothers in the early intervention group classified this help as useful or very useful

in 72%, 78% and 82% of cases in rounds 1, 2 and 3, respectively, compared to 63%, 72% and 73%

of mothers in the late intervention group.

Discussion

The protection, promotion and support of breastfeeding in a community is a complex, challenging

and multisectoral set of interventions that need synergistic engagement by a number of different

actors.32 Our non-randomised controlled study measured the effect of the BFCI on the breastfeeding

rates of a community, not only among infants served by health services. It failed to demonstrate a

statistically significant effect, in particular on the rates of EBF at six months, the primary outcome

under scrutiny. Failure to demonstrate an effect does not necessarily mean that there was no effect.

As shown by our figures and tables, the rates of breastfeeding went up during the project, which

lasted approximately four years. These increases, however, occurred in the LHAs of both groups,

whether they were early or late implementers of the 7 Steps, whether they complied with them to a

greater or lesser extent, and whether they achieved a higher or lower training coverage. None of the

differences was statistically significant. There are many possible explanations for this.

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First, the study may not have had the power to identify small differences as significant. The sample

size, in fact, was established on the assumption that the baseline rate of EBF at six months would be

around 25% and that we would be able to detect an increase of 10%. To our surprise, the baseline

rate of EBF at six months was around 10%,24 and it went up by only 1-2% in four years. The

initially presumed 25% rate was probably the result of inaccurate local statistics. Also, there was a

large drop in EBF between three and six months, most likely due to recommendations by the

majority of paediatrician to introduce solids between four and six months, given the lack of

significant differences by maternal occupation and return to work. Second, the lag time between the

implementation of the 7 Steps and their effects on the rates of breastfeeding may be longer than the

duration of the project. So far, six LHAs, all in the early intervention group, were accredited as

Baby Friendly after passing three phases of external evaluation: two in 2012, close to the end of the

research project, three in 2014 and one in 2015, two and three years after the end of the research

project; other LHAs are still working toward accreditation. Third, the 18 LHAs that volunteered to

participate in the study were already highly committed to the promotion of breastfeeding, compared

to other LHAs nationwide, as shown by the presence of accredited BFHs in one third of the study

areas. The implementation of the 7 Steps might have occurred at a time when breastfeeding was

already on the rise. Lastly, the baseline rates of breastfeeding at 3, 6 and 12 months of our 18 LHAs

were higher than those commonly reported in Italy,8,33 partly due to the above mentioned

commitment to the promotion of breastfeeding, partly because they are located in northern and

central Italy, where rates of breastfeeding are usually higher than in southern regions.34 It may be

harder to increase breastfeeding rates starting from a higher than from a lower level.

A comparison with the trends in the rates of breastfeeding in the same regions where the 18

participating LHAs are located, and during approximately the same period, may help understand if

the small increases reported were associated with BFCI activities or not. This is possible only for

three regions: Lombardia (5 out of its 15 LHAs were included in the BFCI project), Emilia

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Romagna (3 of 11), and Friuli Venezia Giulia (2 of 6). In Lombardia, the rate of EBF at the first

immunization (2-3 months of age) was 38% in 2006 and 47% in 2012; at the second (around five

months of age), it went up from 19% to 27% in the same period.35 In Emilia Romagna, the rates of

EBF at the first and second immunization went up from 47% to 48% and down from 41% to 30%,

respectively, between 2008 and 2011.36 In Friuli Venezia Giulia, the rate of EBF at the second

immunization was 38% in 2004,37 and it went down to 34% in 2011.

38 Our data, however, are very

accurate; the age of the infant, for example, is the exact age plus or minus a week. Instead, the data

from the three regions above refer to infants whose ages may be within a range of one or two

months. They may also be less standardized, and perhaps biased, because they are gathered by

professionals in their own LHA, while our data were collected by independent interviewers. The

samples used in routine surveillance systems may also be less representative than in our sample.

More recently, the National Institute of Statistics published a preliminary report of a survey on

pregnancy, childbirth and breastfeeding carried out in 2013 on a nationally representative sample.39

The results, which are not yet broken down by region, show that between 2005 and 2013 the

initiation of breastfeeding went up from 81.4% to 85.5%, while the median duration increased from

7.3 to 8.3 months, with small differences between macroregions. The survey indicates that there is a

general upward trend, but unfortunately it does not allow to gauge the effect of the BFCI, because it

does not report trends in the rates of EBF.

Our study has some limitations. As it was impossible to randomise the 18 LHAs, the results may be

biased by some residual confounding, despite our efforts to adjust data for well-known confounders

before any comparison between groups. As already mentioned, our study might not have the power

to identify small statistically significant improvements in breastfeeding rates. In addition, it may

have been too short: the effects of the BFCI may become evident over a longer period. Finally, our

study was carried out in a real-life situation. This means that the actual implementation of the

intervention did not necessarily follow the timing and mode proposed by the research protocol, and

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was instead adapted to each reality and tailored to the local situation.21 For example, the

development and approval of a written policy (Step 1) may take different amounts of time in

different LHAs, because of factors such as the continuity and commitment of decision makers, as

well as the complexity of the organization. Some of the 18 LHAs are small and compact, whereas

others are large and located in cities like Rome, Milan and Bologna, where the number of actors is

much higher. This has a bearing on the implementation of Step 2; it is easier to conduct courses

where the number of health professionals is small and stable, while it is much more difficult to

achieve a high coverage with large numbers of professionals and a high turnover. Similar

considerations are relevant for the other steps, and particularly for Step 6, the provision of a

welcoming atmosphere for breastfeeding families, and Step 7, the promotion of co-operation

between healthcare staff, breastfeeding support groups and the local community, which are closely

related. With such a heterogeneous and continuously changing group of study units, it was difficult

to decide what to compare with what, making the interpretation of results very problematic.

To conclude, the BFCI is a complex intervention carried out in socially and geographically different

areas.22 Implementing the 7 Steps requires years of hard work geared toward sustainable changes by

policy and decision makers, all categories of health professionals, public and private health

organizations, mother-to-mother support groups, volunteer organizations and local administrators.

The challenge is to modify the practices of health care professionals and achieve organizational

changes, an objective that is hard to achieve even in the BFHI,32,40 a much less complex initiative,

but also to shape and activate mutually supportive networks. It was encouraging to see all the

coordinated efforts being made in a coordinated way in the 18 LHAs that volunteered to participate

in this project. But complex interventions are not only difficult to implement, it is difficult to assess

their effects in real life.41 The design and methods used in this study are far from perfect, but it

would be difficult to measure the effect of the BFCI, if any, using the rigorous methods of a

randomized controlled trial. The project is already bringing about changes in the way breastfeeding

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is protected, promoted and supported in the 18 LHAs. This study does not allow to determine that

the BFCI is effective nor that it is ineffective, but it has paved the way for better practices in the 18

LHAs and hopefully in other regions of Italy and in other countries.

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Acknowledgements

This work was supported by a financial contribution from the Institute for Maternal and Child

Health IRCCS Burlo Garofolo, Trieste, Italy (research grant n. 32/08), and by funds made available

by the Italian Committee for UNICEF and by each of the participating LHAs for local activities.

The study could not have been carried out without the commitment of dozens of dedicated health

professionals in the 18 study sites, too many to name individually, and the dedication of the

interviewers based at the School of Management and Health in Pisa, Italy. Special thanks to

Leonardo Speri, former coordinator of the BFHI/BFCI Task Force of the Italian Committee for

UNICEF, who strongly supported the idea of setting up this research project.

The study was approved by the Ethics Committees of the Institute for Maternal and Child Health

IRCCS Burlo Garofolo in Trieste and of the 18 participating Local Health Authorities: Bassano del

Grappa, Biella, Bologna, Cesena, Forlì, Friuli Occidentale, Mantova, Marche, Massa Carrara,

Milano, Milano 1, Milano 2, Oristano, Roma B, Sondrio, Trieste, Verbania and Verona.

The following are members of the BFCI Study Group, in addition to the main authors: Alessandra

Knowles, Paola Pani, Claudia Carletti (Institute for Maternal and Child Health IRCCS Burlo

Garofolo, Trieste); Annacatia Miola, Stefania Battocchio, Paola Dal Zotto (Local Health Authority,

Bassano del Grappa); Emiliana Mosca, Angelo Penna, Antonella Tedesco (Local Health Authority,

Biella); Franco Garofalo, Anna Perona (Department of Paediatrics, Biella Hospital); Paola Lenzi,

Marilina Colombo, Cledemaria Garavini (Local Health Authority, Bologna); Massimo Farneti,

Marcella Lombardi (Local Health Authority, Cesena); Anna Maria Baldoni, Laura Borghesi, Paola

Dalla Casa, Enrico Marchiani, Claudia Zoli (Local Health Authority, Forlì); Federica Braida,

Oriana Raminelli, Anna Furlan (Local Health Authority, Pordenone); Fiorella Talassi, Loretta

Grossi, Gabriele Gianella, Paola Mussini (Local Health Authority, Mantova); Rita Gatti, Grazia

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Pompilio (Maternal and Child Health Centre, Loreto); Marco Morbidoni (Department of

Epidemiology, Ancona); Mauro Tiriduzzi, Nadia Liberatore, Susi Campanari, Paola Catena

(Department of Obstetrics and Gynaecology, Osimo Hospital); Laura Polenta, Roberta Freddara

(Salesi Hospital, Ancona); Fabiola Salvetti, Cinzia Luzi, Romana Prosperi Porta (Department of

Pediatrics, Massa Carrara Hospital); Rita Mascheroni, Miriam Lelli, Graziella Cattaneo, Raffaella

Gennaretti, Antonia Tomaselli (Local Health Authority, Milan); Maria Elena Pirola, Domenico

Arensi, Giovanni Beghi, Gigliola Ronchi, Piera Ceresa, Silvano Santucci (Local Health Authority,

Milan 1); Luigi Acerbi, Maura Franzetti, Roberto Lucchini, Giuseppina De Gasperi (Local Health

Authority, Milan 2); Maria Antonietta Grimaldi (Local Health Authority, Oristano); Patrizia

Auriemma, Patrizia Proietti, Elisa Lazzaro (Local Health Authority, Rome B); Eloisa Del Curto,

Patrizia Sossi, Livia Tabacchi, Paola Abbiati (Local Health Authority, Sondrio); Maria Vittoria Sola

(Local Health Authority, Trieste); Andrea Guala, Raffaella Visentin, Luigina Boscardini, Elena

Ferzetti, Laura Cantalupi (Local Health Authority, Verbano-Cusio-Ossola); Emanuela Battisti,

Daniela Dainese, Francesca Lazzari, Elisa Pastorelli (Local Health Authority, Verona).

Contributors: AC designed and coordinated the study, participated in data analysis and

interpretation, and drafted and revised the paper. He acts as guarantor. MEB and EMC pilot tested

and developed the BFCI tools used in the study, were in charge of monitoring the implementation

of BFCI activities by gathering and analysing periodic reports from the study sites, and contributed

to the interpretation of results. AM and LCES centralized and checked all the data gathered in the

three rounds of data collection in a continuous feedback with the study sites, were in charge of

making the datasets ready for analysis, and contributed to the interpretation of results. AMM was

responsible for all the CATI interviews and prepared the relative datasets. MM carried out the

statistical analysis. All the members of the BFCI Study group participated in the implementation of

BFCI activities and in the collection of data for the first interview. All co-authors, including the

members of the BFCI Study Group, approved the final version of the manuscript.

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The manuscript’s guarantor affirms that this manuscript is an honest, accurate, and transparent

account of the study being reported; that no important aspects of the study have been omitted; and

that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Data sharing: the full dataset is available on reasonable request from the corresponding author at

[email protected]. Consent for data sharing was not obtained, but the presented data

are anonymised and risk of identification is low.

Competing interests: none declared.

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Figures’ titles

Figure 1. A sketch of the study design.

Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round

of data collection.

Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round

of data collection.

Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of

data collection.

Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data

collection.

Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data

collection.

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Figure 1. A sketch of the study design. 264x200mm (96 x 96 DPI)

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Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round of data collection.

169x112mm (96 x 96 DPI)

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Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round of data collection.

169x112mm (96 x 96 DPI)

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Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of data collection.

169x112mm (96 x 96 DPI)

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Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data collection.

169x112mm (96 x 96 DPI)

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Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data collection.

169x112mm (96 x 96 DPI)

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Appendix

Table A1. Subjects enrolled and followed up to 12 months by LHA in the early and late intervention groups and by round of data collection

Group LHA Assigned

sample

size

Round 1

(01/09/09-31/03/10)

Round 2

(01/09/10-31/03/11)

Round 3

(01/09/11-31/03/12)

Total

Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss

Early

interv

ention

5 124 124 103 17% 126 115 9% 129 116 10% 379 334 12%

6 48 48 38 21% 47 43 9% 47 42 11% 142 123 13%

8 54 56 52 7% 61 55 10% 58 50 14% 175 157 10%

9 121 122 99 19% 122 93 23% 123 105 15% 367 297 19%

10 109 109 91 17% 112 105 5% 113 99 12% 334 295 12%

14 122 120 96 20% 117 102 13% 122 109 11% 359 307 14%

15 126 126 117 7% 127 111 13% 126 107 15% 379 335 12%

16 134 134 121 10% 135 122 10% 134 119 11% 403 362 10%

18 103 103 81 21% 103 94 9% 103 89 14% 309 264 15%

Total 942 942 798 15% 949 840 11% 955 836 12% 2846 2474 13%

Late in

tervention

1 136 139 117 16% 142 125 12% 140 122 13% 421 364 14%

2 85 94 77 18% 101 92 9% 100 88 12% 295 257 13%

3 50 51 37 27% 49 42 14% 47 40 15% 147 119 19%

4 143 147 131 11% 142 133 6% - - - 289 264 9%

7 115 129 101 22% - - - 130 118 9% 259 219 15%

11 62 61 54 11% 61 49 20% 62 53 15% 184 156 15%

12 68 68 56 18% 67 52 22% 69 55 20% 204 163 20%

13 43 53 50 6% 53 43 19% 51 43 16% 157 136 13%

17 97 97 89 8% 98 80 18% 97 84 13% 292 253 13%

Total 799 839 712 15% 713 616 14% 696 603 13% 2248 1931 14%

Grand total 1741 1781 1510 15% 1662 1456 12% 1651 1439 13% 5094 4405 14%

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Table A2. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by early and late

intervention groups and round of data collection. Late intervention group at round 1 of data collection as comparator. Statistically significand

differences (p<0.05) in bold.

Breastfeeding

indicators

Round of

data

collection


AR

(%)

95% CI

(%)

OR 95% CI AR

(%)

95% CI

(%)

OR 95% CI

EBF at

discharge

(recall 24 h)

1 87.2 83.4-91.1 1.03 0.62-1.70 86.9 82.7-91.1 1 -

2 88.4 84.8-92.1 1.15 0.69-1.91 85.6 80.9-90.2 0.89 0.61-1.31

3 87.4 83.5-91.3 1.04 0.63-1.74 86.4 82.0-90.8 0.96 0.65-1.40

EBF at

discharge

(from birth)

1 72.2 62.0-82.5 1.36 0.66-2.76 65.7 54.0-77.5 1 -

2 73.6 63.6-83.6 1.45 0.71-2.96 70.2 59.1-81.2 1.23 0.90-1.67

3 73.1 63.0-83.2 1.41 0.69-2.89 73.5 63.3-83.8 1.45 1.05-1.99

EBF at 3

months

(recall 24 h)

1 57.7 52.6-62.8 1.13 0.86-1.49 54.7 49.2-60.2 1 -

2 57.1 51.9-62.3 1.10 0.83-1.45 54.5 48.8-60.2 0.99 0.79-1.25

3 61.8 56.8-66.9 1.34 1.01-1.77 58.1 52.4-63.7 1.15 0.90-1.46

EBF at 3

months

(recall 7 d)

1 48.6 42.9-54.3 1.13 0.82-1.55 45.6 39.7-51.6 1 -

2 52.0 46.3-57.7 1.29 0.94-1.78 51.4 45.2-57.6 1.26 1.00-1.58

3 54.9 49.2-60.6 1.45 1.05-2.00 51.4 45.1-57.6 1.26 0.99-1.59

EBF at 6

months

(recall 24 h)

1 8.6 5.6-11.7 1.17 0.67-2.05 7.4 4.6-10.3 1 -

2 7.3 4.6-9.9 0.98 0.55-1.71 8.3 5.1-11.5 1.13 0.77-1.65

3 7.3 4.6-9.9 0.97 0.55-1.71 9.3 5.8-12.8 1.27 0.86-1.87

EBF at 6

months

(recall 7 d)

1 5.2 3.0-7.3 0.93 0.50-1.73 5.5 3.2-7.9 1 -

2 5.2 3.1-7.3 0.93 0.50-1.72 6.7 3.9-9.5 1.22 0.80-1.84

3 5.0 2.9-7.1 0.90 0.49-1.66 7.1 4.1-10.0 1.30 0.85-1.98

ABF at 6

months

(recall 24 h)

1 67.8 63.1-72.6 1.18 0.94-1.48 64.1 58.9-69.3 1 -

2 66.9 62.1-71.7 1.13 0.90-1.42 63.7 58.3-69.1 0.98 0.77-1.24

3 69.1 64.4-73.8 1.25 0.99-1.57 66.5 61.2-71.9 1.11 0.87-1.42

ABF at 12

months

(recall 24 h)

1 32.0 27.2-36.8 1.12 0.86-1.45 29.7 24.8-34.5 1 -

2 34.8 29.9-39.6 1.26 0.98-1.63 31.1 26.0-36.2 1.07 0.84-1.37

3 35.9 31.0-40.9 1.33 1.03-1.72 34.8 29.4-40.1 1.26 0.98-1.62

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Table A3. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by compliance with the

intervention and round of data collection. Non-compliance group at round 1 of data collection as comparator. Statistically significand differences

(p<0.05) in bold.

Breastfeeding

indicators

Round of

data

collection

Compliance group Non-compliance group

AR

(%)

95% CI

(%)

OR 95% CI AR

(%)

95% CI

(%)

OR 95% CI

EBF at

discharge

(recall 24 h)

1 87.2 83.5-90.8 1.02 0.60-1.75 86.9 82.1-91.8 1 -

2 86.9 83.2-90.6 0.99 0.58-1.70 88.0 83.3-92.7 1.10 0.71-1.71

3 87.9 84.4-91.4 1.09 0.64-1.88 84.9 79.5-90.3 0.85 0.55-1.30

EBF at

discharge

(from birth)

1 70.3 60.4-80.2 1.16 0.53-2.50 67.2 53.9-80.5 1 -

2 69.6 59.6-79.6 1.12 0.52-2.41 76.2 64.9-87.4 1.56 1.09-2.23

3 72.2 62.7-81.7 1.27 0.59-2.75 74.5 62.9-86.0 1.42 1.00-2.04

EBF at 3

months

(recall 24 h)

1 60.5 56.9-64.2 1.64 1.26-2.13 48.3 43.3-53.4 1 -

2 58.3 54.6-62.0 1.49 1.15-1.93 51.4 46.1-56.7 1.13 0.88-1.46

3 63.4 59.9-67.0 1.85 1.43-2.41 54.6 49.4-59.8 1.28 0.99-1.67

EBF at 3

months

(recall 7 d)

1 50.4 45.7-55.1 1.42 1.03-1.95 41.8 35.8-47.8 1 -

2 53.4 48.7-58.0 1.60 1.16-2.19 48.8 42.4-55.2 1.33 1.03-1.72

3 56.2 51.6-60.9 1.79 1.30-2.46 48.5 42.1-54.8 1.31 1.01-1.71

EBF at 6

months

(recall 24 h)

1 9.6 6.6-12.5 1.67 0.93-3.01 5.9 3.3-8.6 1 -

2 8.1 5.5-10.6 1.38 0.77-2.49 7.7 4.3-11.0 1.31 0.83-2.08

3 9.2 6.3-12.0 1.60 0.89-2.88 6.4 3.5-9.3 1.08 0.66-1.76

EBF at 6

months

(recall 7 d)

1 6.1 3.8-8.3 1.39 0.72-2.67 4.4 2.2-6.7 1 -

2 6.1 3.8-8.3 1.39 0.73-2.67 5.8 2.9-8.7 1.32 0.80-2.19

3 6.7 4.3-9.2 1.55 0.81-2.98 4.5 2.1-6.8 1.01 0.59-1.73

ABF at 6

months

(recall 24 h)

1 68.7 64.5-72.9 1.40 1.07-1.84 61.0 55.4-66.6 1 -

2 67.3 63.0-71.5 1.31 1.01-1.71 61.7 55.9-67.5 1.03 0.79-1.34

3 70.1 66.0-74.3 1.50 1.15-1.97 64.0 58.4-69.6 1.14 0.87-1.48

ABF at 12

months

(recall 24 h)

1 33.0 28.6-37.4 1.31 0.97-1.76 27.3 22.2-32.5 1 -

2 35.0 30.5-39.4 1.43 1.07-1.92 29.8 24.3-35.4 1.13 0.86-1.50

3 37.2 32.6-41.7 1.57 1.17-2.11 32.5 26.9-38.2 1.28 0.96-1.71

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The effectiveness of the Baby Friendly Community Initiative

in Italy: a non-randomised controlled study

Journal: BMJ Open

Manuscript ID bmjopen-2015-010232.R1

Article Type: Research

Date Submitted by the Author: 04-Feb-2016

Complete List of Authors: Cattaneo, Adriano; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Bettinelli, Maria; Local Health Authority, Maternal and Child Health Unit, Department of Primary Care Chapin, Elise; Italian Committee for UNICEF, Baby Friendly Initiatives Macaluso, Anna; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Health Services Research and International Health Córdova do Espírito Santo, Lílian; National Council for Technological and Scientific Development Murante, Anna Maria; Scuola Superiore Sant'Anna, Istituto di MAnagement - Laboratorio Management e sanità Montico, Marcella; Institute for Maternal and Child Health IRCCS Burlo Garofolo, Epidemiology and Biostatistics

<b>Primary Subject Heading</b>:

Health services research

Secondary Subject Heading: Paediatrics

Keywords: Breastfeeding, Baby-Friendly Initiatives, Italy


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1

The effectiveness of the Baby Friendly Community Initiative in Italy: a non-randomised controlled

study

Running title: Baby-Friendly Community Initiative

Adriano Cattaneo, Maria Enrica Bettinelli, Elise Chapin, Anna Macaluso, Lílian Córdova do

Espírito Santo, Anna Maria Murante, Marcella Montico, on behalf of the BFCI Study Group

Health Services Research and International Health, Institute for Maternal and Child Health IRCCS

Burlo Garofolo, Via dell’Istria 65/1, 34137 Trieste, Italy (Adriano Cattaneo, Anna Macaluso),

Maternal and Child Health Unit, Department of Primary Care, Local Health Authority, 20122

Milan, Italy (Maria Enrica Bettinelli), Baby Friendly Initiatives, Italian Committee for UNICEF,

00185 Rome, Italy (Elise M. Chapin), Grant recipient, National Council for Technological and

Scientific Development, Porto Alegre, Brazil (Lílian Córdova do Espírito Santo), Management and

Health Laboratory, Institute of Management, Scuola Superiore Sant’Anna, 56127 Pisa, Italy (Anna

Maria Murante), Epidemiology and Biostatistics, Institute for Maternal and Child Health IRCCS

Burlo Garofolo, 34137 Trieste, Italy (Marcella Montico).

Correspondence to: [email protected]; mobile +393206797647

Keywords: breastfeeding, Baby Friendly Initiatives, Italy

Word count (text): 4553

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Abstract

Objective. To assess the effectiveness of the Baby Friendly Community Initiative (BFCI) on

exclusive breastfeeding to six months.

Design. Controlled, non-randomised trial.

Setting. 18 Local Health Authorities in 9 regions of Italy.

Participants. 5094 mother/infant dyads in three cohorts followed-up to 12 months after birth in three

rounds of data collection: at baseline, after implementation of the intervention in the early

intervention group, and after implementation in the late intervention group. 689 (14%) dyads did

not complete the study.

Intervention. Implementation of the 7 Steps of the BFCI.

Main outcome measures. The rate of exclusive breastfeeding at 6 months was the primary outcome;

breastfeeding at discharge, 3 and 12 months were also measured.

Results. The crude rates of exclusive breastfeeding at discharge, 3 and 6 months, and of any

breastfeeding at 6 and 12 months increased at each round of data collection after baseline in both

the early and late intervention groups. At the end of the project, 10% of infants were exclusively

breastfed at 6 months and 38% were continuing to breastfeed at 12 months. However, the

comparison by adjusted rates and logistic regression failed to show statistically significant

differences between groups and rounds of data collection in the intention-to-treat analysis, but also

when compliance with the intervention and training coverage were taken into account.

Conclusions. The study failed to demonstrate an effect of the BFCI on the rates of breastfeeding.

This may be due to, among other factors, to the time needed to observe an effect on breastfeeding

following this complex intervention.

Word count: 254

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Strengths and limitations of this study

• Implementation of a complex multisectoral intervention for the protection, promotion and

support of breastfeeding, with synergistic engagement of many different actors.

• Controlled, though non-randomised, trial with possible effect measured in three rounds of

data collection, at baseline and before and after a phased implementation of the intervention.

• Rates of breastfeeding compared between groups of local health authorities by intention to

treat, compliance with the intervention and training coverage.

• Rates of breastfeeding increased overall during the four years of the study, but this may not

have had the power to identify small differences as significant.

• The effects of a complex intervention such as the Baby Friendly Community Initiative may

need more than the four years of the study to be observed.

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Introduction

The Baby Friendly Hospital Initiative (BFHI) is an evidence-based effective intervention that

contributes to increasing the initiation, exclusivity and duration of breastfeeding.1,2 Alone, however,

it cannot achieve the goals recommended by WHO, UNICEF and many national and professional

policies, i.e. exclusive breastfeeding (EBF) for six months and continued breastfeeding, with

adequate complementary foods, up to two years and beyond.3-6 Worldwide, rates of EBF to 6

months fall short of those recommended;7-9 interventions at the community level, in addition to the

hospital-based ones, are needed to improve them.10 Several community interventions, such as

primary-care-based educational programmes,11,12 competent professional support at home or in

health facilities,13 home visits by trained professionals,

14 home-based peer counselling,

15 or the

involvement of fathers,16,17 have been shown to be effective. In some countries, these interventions

have been integrated into Baby Friendly Community Initiatives (BFCI),18-20 generally considered as

an appropriate framework.21

The Italian Committee for UNICEF, which promotes and coordinates the BFHI in Italy, established

a working group to adapt and develop the BFCI for the national health system, in collaboration with

the Local Health Authority (LHA) of Milan, where it was initially piloted and later launched in

2007. The BFCI is based on the Seven Point Plan used in the UK and New Zealand, and includes

tools for planning, implementation, monitoring and evaluation described in a companion paper.22

Briefly, the 7 Steps of the BFCI (Table 1) are supposed to be implemented in all the non-hospital-

based health facilities of a LHA. These include health centres, mother and child health clinics,

family health centres, public and private medical, obstetric and paediatric practices, day care

centres, and, where present, public pharmacies. All the health and social workers of these facilities

have to be trained, in courses of different duration, to implement a policy previously developed by a

multidisciplinary team and approved by the LHA management. Health professionals are trained to

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help breastfeeding as well as formula-feeding mothers when and where they ask for support.

Moreover, by implementing Step 6, the LHA is required to create breastfeeding-friendly

environments not only in its premises and facilities, but also in other community and public places.

So called “baby pit stops” are created in public locations or businesses (shops, libraries, pharmacies,

etc.) where nursing mother can feel welcome. These places are free, do not require any purchase,

and become part of a network promoted by UNICEF Italy, with a periodic review by a consumers’

group or volunteers. Other initiatives included in this step are breastfeeding-friendly day care and

workplaces which are designed so that breastfeeding can once again be considered an act that can

be done in public. The day care centres have guidelines for the use of mother’s milk and welcome

breastfeeding mothers who want to feed their children when they drop them off or pick them up.

Step 7 focuses on networking with other services and mother-to-mother and peer support groups

that are not part of the health system. In addition to these groups, support may be offered through a

breastfeeding helpline, local health clinics, hospitals, or baby-friendly physicians’ offices, or

breastfeeding-friendly pharmacies (BFF). The BFF is a separate programme that requires all staff to

complete a 15-hour course, to promote breastfeeding as the norm, to keep breastmilk substitutes,

bottles and teats behind the counter with prescription drugs, to sell them only upon specific request,

and to abide, like all health facilities and professionals in the LHA, by the International Code of

Marketing of Breast-Milk Substitutes.

Table 1. The Seven Steps of the Baby Friendly Community Initiative

1. Have a written breastfeeding policy that is routinely communicated to all staff.

2. Train all staff to implement the breastfeeding policy.

3. Inform all pregnant women and their families about the benefits and management of

breastfeeding.

4. Support mothers to initiate and sustain breastfeeding.

5. Encourage exclusive breastfeeding up to 6 months of age, the introduction of appropriate

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complementary foods after 6 months, and continued breastfeeding.

6. Provide a welcoming atmosphere for breastfeeding families.

7. Promote cooperation between health care staff, breastfeeding support groups, and the local

community.

In 2009, 18 LHAs, which had expressed an interest in the BFCI, accepted the invitation from the

Italian Committee for UNICEF of working towards BFCI accreditation. This was an opportunity to

set up a research project to look at the effectiveness of the BFCI in terms of rates and duration of

EBF to six months, a recognized research priority.23 The methods and some baseline data of this

project have already been reported in a second companion paper.24 This third paper reports the final

results.

Methods

The methods of this research project have already been described.24 Briefly, this controlled trial

involved 18 LHAs in 9 regions of northern and central Italy. Some of these LHAs, however, had

already started implementing BFCI activities before the study was designed: Milan because it had a

leading role in developing the materials and tools and pilot testing them; others because they had

been part of the working group that adapted the BFCI for Italy, or had previously worked on

developing draft policies, or had conducted some limited staff training, especially where there was a

Baby Friendly Hospital (BFH). For these reasons, it was impossible to randomize the 18 LHAs into

intervention and control groups. It was instead decided to implement the 7 Steps in a phased way,

first in an early intervention group of LHAs that had already implemented some BFCI activities

(LHAs 5, 6, 8, 9, 10, 14, 15, 16, 18), then, after about 12 months, in the remaining ones (LHAs 1, 2,

3, 4, 7, 11, 12, 13, 17). Assignment to the early or late intervention group was preceded by pairing

LHAs based on reported rates of EBF at around 5 months of age, size of the population, and setting

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and population density (i.e. whether the LHA was mostly urban or rural). Figure 1 shows the study

design and the sample size at each round of data collection, at baseline, after implementation of

activities in the early intervention group, and after implementation in the late intervention group.

The rate of EBF at 6 months was the primary outcome of the study. To compare these rates between

groups and within them over time, data were gathered in three rounds. At each round of data

collection, starting in the fall of 2009, cohorts of infants were followed from birth to 12 months,

with interviews at discharge and at 3, 6 and 12 months, in each of the three rounds. Mothers were

recruited consecutively in the hospitals serving the 18 LHAs, until the intended sample size was

attained. After obtaining informed consent, the first interview with the mother was conducted face-

to-face just before discharge using a 36-item questionnaire that included three questions on feeding

both within the previous 24 hours and from birth (Has the baby had breastmilk? Has the baby had

formula? Has the baby had other fluids, and if so what?), questions on potential confounders, as

well as basic information used to identify the subject. If, for any reason, it was impossible to

interview the mother during hospital stay, the interview was carried out by telephone within one

week of giving birth; this occurred with 212 (12%) mothers. These interviews were performed by

the staff in charge of the BFCI in each LHA. The interviews at 3, 6 and 12 months included five

yes/no questions on foods and fluids taken in the previous 24 hours (breastmilk, formula, animal

milks, non-nutritive fluids, and solids or semisolids), plus an additional question for infants fed only

breastmilk on other foods and fluids taken in the previous 7 days, to compensate for the well-known

overestimate of EBF using a 24-hour recall.25,26 These questions, complemented in the interview at

12 months by questions on breastfeeding problems and ways they were solved or not, were

administered by researchers of the Management and Health Laboratory at Scuola Superiore

Sant’Anna, Pisa, specialized in conducting surveys using Computer-Assisted Telephone

Interviewing (CATI) methods. These interviewers were unaware of the assignment to the early or

late intervention groups. The different categories of feeding were automatically derived from the

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different combinations of answers.27,28 All infants were followed up to 12 months of age

irrespective of their feeding status. The interviews at 12 months in the third round of data collection

were concluded in March of 2012.

The sample size for each cohort was established on the assumption that the BFCI could result in a

10% increase in the rate of EBF at 6 months, from the baseline 25% estimate, as a weighted and

adjusted average of the range from 10% to 60% reported for 2007 or 2008 by the 18 LHAs at

around 5 months of age. These reports were based on data gathered most often at immunization or,

less often, during small cross-sectional or longitudinal surveys, with questionnaires, definitions of

feeding categories and recall periods that were not standardized, and on samples that might have not

represented the population. Based on the above assumption, the sample size for a controlled trial

with a precision of 5% and a power of 80% would amount to 348 subjects per study arm. Due to the

cluster design of the study, this number was doubled to 1392 subjects, 696 per study arm,

considering a possible and conservative design effect of 2. The final sample size of 1740 mother-

infant pairs per round of data collection takes into account a possible 20% loss to follow up. This

sample size was then distributed among the 18 LHAs in proportion to their estimated number of

annual births. Exclusion criteria were a birth weight lower than 2000 g, any post-partum condition

that required admission into a neonatal intensive care unit, the practical impossibility of conducting

the interview (mother or relative unable to understand Italian, English, French or Spanish), and

residence outside the area covered by the LHA. Twins were recruited as separate subjects. As

described in the first companion paper,22 data collection included a self-assessment questionnaire

completed by the 18 LHAs on the progress made in implementing the 7 Steps, each step having a

set of 3 to 11 criteria based on the same model used for the self-assessment of the BFHI.29 In

addition, each LHA was supposed to develop annual action plans and to report on the degree of

implementation.

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After a phase of planning and pilot testing of the tools,22 baseline data collection started in

September 2009 and was successfully completed; the second and third rounds were completed as

planned. Data from face-to-face interviews were manually inputted into customized EpiData Files,

and later exported to MS Excel, by the research assistants in each of the 18 sites. Those from the

CATI system (at 3, 6 and 12 months) were recorded answer-by-answer in real time and

automatically saved into a separate relational database, one for each round of data collection, and

were then extracted to MS Excel files. Finally, all the data from each round were integrated into a

single MS Excel file in Trieste, using the individual ID codes for record linkage. Data were then

checked for completeness, consistency and accuracy, and research assistants at the 18 sites were

notified of possible mistakes for correction after comparison with the original paper records. Data

analysis was carried out using Stata 13. Differences in baseline characteristics were analysed with

Chi squared test or t-test as appropriate. Differences in rates of breastfeeding between early and late

intervention groups at different time points were assessed with logistic regression models using a

backward stepwise selection approach that retained only the variables associated with breastfeeding

at the 0.05 level of significance and took into account the effect of the cluster design (cluster

command in Stata 13). The tested variables were: maternal age, nationality, education, paid

occupation, living with a partner, smoking before and during pregnancy, maternal pre-pregnancy

BMI, gestational diabetes, parity, twin pregnancy, attending an antenatal course, birth in a BFH,

type of delivery, analgesia or anaesthesia in labour, intention to breastfeed, gestational age, birth

weight, timing of the first breastfeed, rooming-in, baby-led feeding, use of bottle and/or pacifier

during hospital stay. The results of the logistic regression models were used to obtain adjusted

breastfeeding rates at different ages, with 95% confidence intervals adjusted for the effect of the

cluster design.

Results

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Table A1 in appendix shows the number of subjects enrolled and followed up to 12 months by LHA

in the early and late intervention groups and by round of data collection. The final database includes

5094 records of enrolled mother-baby dyads, including 107 twins (2%), 126 dyads less than the

intended overall sample size due to the failure of two LHAs, both in the late intervention group, to

participate in one of the data collection rounds. For the analysis at three months, 4704 dyads are

available, a loss of 7.7%; at six months, data are available on 4572 dyads, a further 2.8% loss; at 12

months, 4405 dyads completed the series of interviews, for a total loss to follow up of 13.5% (range

of 9% to 20% among LHAs, no significant differences by intervention group and by round of data

collection), less than the 20% predicted when the sample size was calculated. A total of 281 eligible

mothers declined to be enrolled for various reasons; there were no significant differences between

participant and non-participant mothers except for nationality, the proportion of foreign women

being higher among the latter. Table 2 shows the characteristics of the mothers and infants included

in the analysis, by study group. The demographic characteristics of the sample were similar to

national averages in terms of age and education, while the percentage of women with a paid

employment was slightly higher.30 More women in the sample attended antenatal classes than do on

average throughout the country (44% vs. 35%).31 It is also worth noting that the rate of caesarean

delivery (27-29%) was well below the national average of 38%, although slightly fewer women had

term births (90-92% vs. 93%). There were several statistically significant differences between early

and late intervention groups; these differences were accounted for in the multivariate analysis. The

significantly better perinatal care practices reported by mothers in the early intervention group are

probably due to the higher percentage of births in BFHs.

Table 2. Characteristics of the mothers and infants included in the analysis, by study group.

Early intervention Late intervention p-value

Mean (sd) age (years) 32 (5) 32 (5) 0.121

Mean (sd) education (years) 14 (4) 13 (4) <0.001

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Employment: paid occupation 76% 78% 0.095

Italian 85% 85% 0.535

Living with the partner 97% 96% 0.004

Smoking before pregnancy 29% 27% 0.109

during pregnancy 11% 8% 0.003

Referred BMI <25 80% 79% 0.436

25-29.9 14% 15%

>=30 6% 6%

Gestational diabetes 7% 8% 0.021

Primiparae 57% 54% 0.053

Attendance to antenatal classes 44% 44% 0.716

At least one session on BF 82% 87% 0.002

Delivery at term (38-41 weeks) 92% 90% 0.003

Caesarean section rate 27% 29% 0.058

Anaesthesia or analgesia during

labour/delivery (including C-section)

55% 60% <0.001

Mean (sd) birth weight (g) 3304 (443) 3283 (443) 0.092

Previous breastfeeding experience 41% 44% 0.126

Of which <6 months 31% 37% 0.034

6-12 months 45% 42%

13-24 months 20% 18%

>24 months 4% 3%

Intention to breastfeed current baby 99% 98% 0.126

exclusively for at least 6 m 82% 80% 0.184

Birth in a Baby Friendly Hospital 32% 27% <0.001

Baby latched on within 1 hour 61% 67% <0.001

Rooming-in (24h/day, all infants) 77% 80% 0.080

Baby-led BF (breastfed infants) 90% 89% 0.246

Baby used bottle (all infants) 20% 18% 0.001

Baby used pacifier (all infants) 19% 26% <0.001

Figures 2-6 show the crude rates of EBF at discharge (recall from birth) and at three and six months

(recall 7 days), and the crude rates of any breastfeeding at six and 12 months (recall 24 hours). By

the end of the project, almost 70% of infants were exclusively breastfed at discharge, with an

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increasing trend between rounds 1 and 3 of data collection, and with great variation among sites

(range: 26% to 93%). Both the upward trend between the first and the third round of data collection,

and the variation among sites, are present at 3, 6 and 12 months, for both exclusive and any

breastfeeding. At the third round of data collection, the rates of EBF were fairly high at three

months (54% at round 3, range 36% to 66%), but dropped to 8% (range 1% to 23%) at six months.

These rates were lower than expected, even when considering the figures for the 24-hour recall:

10% (range 3% to 23%). At the end of the project, almost 38% of infants were continuing to

breastfeed at 12 months.

Crude rates, however, cannot be used for comparisons, as this was not a randomised trial and

confounding has to be considered. Table 3 shows the adjusted rates of exclusive and any

breastfeeding at different ages and with different recall periods by intervention group and round of

data collection. Though there was a clear pattern of higher rates in the early intervention group,

there were no statistically significant differences between groups and rounds of data collection as

far as adjusted rates at discharge (not shown) are concerned. The lack of a statistically significant

difference between groups had already been noted at baseline,24 when it was in fact expected

because sites were paired by breastfeeding rates, and persisted through the second and third round

of data collection. Table 3 shows an upward trend of the adjusted rates of breastfeeding between

rounds of data collection, with the exception of EBF and ABF at six months in the early

intervention group. Yet none of the differences between and within groups is statistically

significant. The removal of twins from the dataset did not change the results.


with different recall periods by intervention group and round of data collection.

Breastfeeding Early intervention group Late intervention group

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indicators Round n % (95% CI) n % (95% CI)

EBF at 3 m

(recall 24 h)

1 852 58.1 (52.1 – 64.1) 746 52.8 (47.3 – 58.4)

2 845 57.5 (54.4 – 60.7) 645 53.6 (45.7 – 61.6)

3 867 62.3 (59.8 – 64.7) 633 57.9 (53.8 – 62.1)

EBF at 3 m

(recall 7 d)

1 852 49.6 (43.5 – 55.7) 746 43.4 (38.3 – 48.5)

2 845 52.9 (48.7 – 57.2) 645 50.0 (41.5 – 58.4)

3 867 55.9 (52.3 – 59.4) 633 51.1 (47.5 – 54.6)

EBF at 6 m

(recall 24 h)

1 822 9.0 (6.2 – 11.9) 726 7.1 (3.9 – 10.2)

2 835 7.7 (5.4 – 9.9) 636 8.4 (4.7 – 12.2)

3 842 7.6 (4.9 – 10.3) 599 9.6 (7.2 – 12.1)

EBF at 6 m

(recall 7 d)

1 822 5.5 (3.8 – 7.2) 726 5.3 (2.8 – 7.7)

2 835 5.6 (3.7 – 7.4) 636 6.7 (3.7 – 9.8)

3 842 5.4 (2.7 – 8.0) 599 7.6 (5.6 – 9.6)

ABF at 6 m

(recall 24 h)

1 822 67.6 (62.5 – 72.7) 726 62.4 (55.8 – 69.0)

2 835 66.7 (63.5 – 69.9) 636 63.4 (59.4 – 67.3)

3 842 69.0 (66.2 – 71.8) 599 65.4 (61.4 – 69.5)

ABF at 12 m

(recall 24 h)

1 777 32.4 (26.6 – 38.2) 683 28.6 (24.1 – 33.2)

2 820 34.9 (32.4 – 37.5) 611 30.8 (24.0 – 37.6)

3 817 36.2 (32.4 – 40.1) 592 34.9 (30.9 – 39.0)

As the periodic self-assessments had revealed that some of the study sites were making progress in

the implementation of the 7 Steps, while others were lagging behind, we carried out a comparison

by compliance with the intervention, in addition to the analysis by intention to treat. Table 4 shows

the same adjusted rates of breastfeeding of Table 3 after re-grouping the 18 LHAs by compliance

with the intervention. This comparison shows some statistically significant differences between

groups (EBF at three months in rounds 1 and 3, and ABF at six months in rounds 2 and 3) and

between rounds (EBF at three months between rounds 1 and 3 in the non-compliance group), but it

does not show an effect of the intervention. We repeated the same statistical analysis using staff

training to re-group the 18 LHAs into groups with higher and lower training coverage; results (not

shown but available on request) and interpretation did not change. It is interesting to note, however,

that, despite the apparent lack of effect of the intervention and despite similar adjusted rates of

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initiation (between 65% and 72% in both groups), the LHAs in the compliance and higher training

coverage groups presented consistently higher rates of breastfeeding throughout the first year of

life. Once again, the removal of twins did not change the results.


with different recall periods by compliance with the intervention and round of data collection.

Breastfeeding

indicators


Round n % (95% CI) n % (95% CI)

EBF at 3 m

(recall 24 h)

1 978 60.6 (56.2 – 65.0)§ 620 47.6 (43.6 – 51.6)§*

2 979 58.4 (54.9 – 61.9) 511 51.0 (42.8 – 59.1)

3 993 63.5 (61.4 – 65.7)§ 507 54.5 (51.7 – 57.3)§*

EBF at 3 m

(recall 7 d)

1 978 51.1 (46.1 – 56.1)§ 620 39.7 (35.6 – 43.8)§*

2 979 53.9 (49.6 – 58.3) 511 47.3 (38.7 – 55.9)

3 993 56.8 (53.7 – 59.9)§ 507 48.1 (45.1 – 51.2)§*

EBF at 6 m

(recall 24 h)

1 947 9.8 (7.0 – 12.6) 601 5.6 (2.5 – 8.7)

2 956 8.3 (5.5 – 11.1) 515 7.5 (4.1 – 10.9)

3 951 9.4 (6.8 – 12.1) 490 6.5 (3.5 – 9.5)

EBF at 6 m

(recall 7 d)

1 947 6.3 (4.6 – 7.9) 601 4.2 (1.7 – 6.8)

2 956 6.4 (4.0 – 8.8) 515 5.6 (3.1 – 8.1)

3 951 7.0 (4.1 – 9.9) 490 4.7 (2.6 – 6.8)

ABF at 6 m

(recall 24 h)

1 947 68.9 (64.4 – 73.3) 601 59.1 (53.2 – 65.0)

2 956 67.4 (65.2 – 69.6)§ 515 61.1 (57.3 – 65.0)§

3 951 70.3 (67.6 – 73.1)§ 490 62.1 (59.6 – 64.6)§

ABF at 12 m

(recall 24 h)

1 890 33.5 (28.5 – 38.5) 570 26.2 (21.7 – 30.7)

2 931 35.3 (32.2 – 38.4) 500 29.3 (22.3 – 36.3)

3 930 37.6 (34.3 – 40.9) 479 32.1 (28.0 – 36.1)

§ p<0.05 between groups; * p<0.05 between rounds.

We carried out also a logistic regression analysis including all the variables used to adjust the rates

of breastfeeding, plus the rates of EBF at discharge (recall from birth). Tables A2 and A3 in

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appendix show the adjusted rates of breastfeeding and the odd ratios, with their respective 95%

confidence intervals, by early and late intervention and by compliance and non-compliance,

respectively, and by round of data collection, using the rates of the late intervention and non-

compliance groups at round 1 as comparators. Using this logistic regression model, a small number

of odd ratios result in statistically significant differences. These differences, however, do not

indicate a clear association between the BFCI intervention, or compliance with it, and increased

rates of breastfeeding.

Finally, we analysed the answers mothers gave at the 12-month interview when asked if they had

had problems with breastfeeding, where they had looked for help, and whether they thought that

those providing help had solved their problems or not. Overall, the 5094 mothers reported 1082

problems, mainly breast and nipple complaints (39%), not enough milk (32%) and difficulties

latching the baby on (20%), with no statistically significant differences between groups and rounds

of data collection. There were no differences also in the percentage of mothers who sought help for

these problems either. Some relevant statistically significant differences (p<0.05) were found when

mothers were asked to evaluate on a Likert scale the help received by level of usefulness in solving

their problems. Mothers in the early intervention group classified this help as useful or very useful

in 72%, 78% and 82% of cases in rounds 1, 2 and 3, respectively, compared to 63%, 72% and 73%

of mothers in the late intervention group.

Discussion

The protection, promotion and support of breastfeeding in a community is a complex, challenging

and multisectoral set of interventions that need synergistic engagement by a number of different

actors.32 Our non-randomised controlled study measured the effect of the BFCI on the breastfeeding

rates of a community, not only among infants served by health services. It failed to demonstrate a

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statistically significant effect, in particular on the rates of EBF at six months, the primary outcome

under scrutiny. Failure to demonstrate an effect does not necessarily mean that there was no effect.

As shown by our figures and tables, the rates of breastfeeding went up during the project, which

lasted approximately four years. These increases, however, occurred in the LHAs of both groups,

whether they were early or late implementers of the 7 Steps, whether they complied with them to a

greater or lesser extent, and whether they achieved a higher or lower training coverage. None of the

differences was statistically significant. There are many possible explanations for this.

First, the study may not have had the power to identify small differences as significant. The sample

size, in fact, was established on the assumption that the baseline rate of EBF at six months would be

around 25% and that we would be able to detect an increase of 10%. To our surprise, the baseline

rate of EBF at six months was around 10%,24 and it went up by only 1-2% in four years. The

initially presumed 25% rate was probably the result of inaccurate local statistics. Also, there was a

large drop in EBF between three and six months, most likely due to recommendations by the

majority of paediatrician to introduce solids between four and six months, given the lack of

significant differences by maternal occupation and return to work. Second, the lag time between the

implementation of the 7 Steps and their effects on the rates of breastfeeding may be longer than the

duration of the project. So far, six LHAs, all in the early intervention group, were accredited as

Baby Friendly after passing three phases of external evaluation: two in 2012, close to the end of the

research project, three in 2014 and one in 2015, two and three years after the end of the research

project; other LHAs are still working toward accreditation. Third, the 18 LHAs that volunteered to

participate in the study were already highly committed to the promotion of breastfeeding, compared

to other LHAs nationwide, as shown by the presence of accredited BFHs in one third of the study

areas. The implementation of the 7 Steps might have occurred at a time when breastfeeding was

already on the rise. Lastly, the baseline rates of breastfeeding at 3, 6 and 12 months of our 18 LHAs

were higher than those commonly reported in Italy,8,33 partly due to the above mentioned

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commitment to the promotion of breastfeeding, partly because they are located in northern and

central Italy, where rates of breastfeeding are usually higher than in southern regions.34 It may be

harder to increase breastfeeding rates starting from a higher than from a lower level.

A comparison with the trends in the rates of breastfeeding in the same regions where the 18

participating LHAs are located, and during approximately the same period, may help understand if

the small increases reported were associated with BFCI activities or not. This is possible only for

three regions: Lombardia (5 out of its 15 LHAs were included in the BFCI project), Emilia

Romagna (3 of 11), and Friuli Venezia Giulia (2 of 6). In Lombardia, the rate of EBF at the first

immunization (2-3 months of age) was 38% in 2006 and 47% in 2012; at the second (around five

months of age), it went up from 19% to 27% in the same period.35 In Emilia Romagna, the rates of

EBF at the first and second immunization went up from 47% to 48% and down from 41% to 30%,

respectively, between 2008 and 2011.36 In Friuli Venezia Giulia, the rate of EBF at the second

immunization was 38% in 2004,37 and it went down to 34% in 2011.

38 Our data, however, are very

accurate; the age of the infant, for example, is the exact age plus or minus a week. Instead, the data

from the three regions above refer to infants whose ages may be within a range of one or two

months. They may also be less standardized, and perhaps biased, because they are gathered by

professionals in their own LHA, while our data were collected by independent interviewers. The

samples used in routine surveillance systems may also be less representative than in our sample.

More recently, the National Institute of Statistics published a preliminary report of a survey on

pregnancy, childbirth and breastfeeding carried out in 2013 on a nationally representative sample.39

The results, which are not yet broken down by region, show that between 2005 and 2013 the

initiation of breastfeeding went up from 81.4% to 85.5%, while the median duration increased from

7.3 to 8.3 months, with small differences between macroregions. The survey indicates that there is a

general upward trend, but unfortunately it does not allow to gauge the effect of the BFCI, because it

does not report trends in the rates of EBF.

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Our study has some limitations. As it was impossible to randomise the 18 LHAs, the results may be

biased by some residual confounding, despite our efforts to adjust data for well-known confounders

before any comparison between groups. As already mentioned, our study might not have the power

to identify small statistically significant improvements in breastfeeding rates. In addition, it may

have been too short: the effects of the BFCI may become evident over a longer period. Finally, our

study was carried out in a real-life situation. This means that the actual implementation of the

intervention did not necessarily follow the timing and mode proposed by the research protocol, and

was instead adapted to each reality and tailored to the local situation.21 For example, the

development and approval of a written policy (Step 1) may take different amounts of time in

different LHAs, because of factors such as the continuity and commitment of decision makers, as

well as the complexity of the organization. Some of the 18 LHAs are small and compact, whereas

others are large and located in cities like Rome, Milan and Bologna, where the number of actors is

much higher. This has a bearing on the implementation of Step 2; it is easier to conduct courses

where the number of health professionals is small and stable, while it is much more difficult to

achieve a high coverage with large numbers of professionals and a high turnover. Similar

considerations are relevant for the other steps, and particularly for Step 6, the provision of a

welcoming atmosphere for breastfeeding families, and Step 7, the promotion of co-operation

between healthcare staff, breastfeeding support groups and the local community, which are closely

related. With such a heterogeneous and continuously changing group of study units, it was difficult

to decide what to compare with what, making the interpretation of results very problematic.

To conclude, the BFCI is a complex intervention carried out in socially and geographically different

areas.22 Implementing the 7 Steps requires years of hard work geared toward sustainable changes by

policy and decision makers, all categories of health professionals, public and private health

organizations, mother-to-mother support groups, volunteer organizations and local administrators.

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The challenge is to modify the practices of health care professionals and achieve organizational

changes, an objective that is hard to achieve even in the BFHI,32,40 a much less complex initiative,

but also to shape and activate mutually supportive networks. It was encouraging to see all the

coordinated efforts being made in a coordinated way in the 18 LHAs that volunteered to participate

in this project. But complex interventions are not only difficult to implement, it is difficult to assess

their effects in real life.41 The design and methods used in this study are far from perfect, but it

would be difficult to measure the effect of the BFCI, if any, using the rigorous methods of a

randomized controlled trial. The project is already bringing about changes in the way breastfeeding

is protected, promoted and supported in the 18 LHAs. This study does not allow to determine that

the BFCI is effective nor that it is ineffective, but it has paved the way for better practices in the 18

LHAs and hopefully in other regions of Italy and in other countries.

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Acknowledgements

This work was supported by a financial contribution from the Institute for Maternal and Child

Health IRCCS Burlo Garofolo, Trieste, Italy (research grant n. 32/08), and by funds made available

by the Italian Committee for UNICEF and by each of the participating LHAs for local activities.

The study could not have been carried out without the commitment of dozens of dedicated health

professionals in the 18 study sites, too many to name individually, and the dedication of the

interviewers based at the School of Management and Health in Pisa, Italy. Special thanks to

Leonardo Speri, former coordinator of the BFHI/BFCI Task Force of the Italian Committee for

UNICEF, who strongly supported the idea of setting up this research project.

The study was approved by the Ethics Committees of the Institute for Maternal and Child Health

IRCCS Burlo Garofolo in Trieste and of the 18 participating Local Health Authorities: Bassano del

Grappa, Biella, Bologna, Cesena, Forlì, Friuli Occidentale, Mantova, Marche, Massa Carrara,

Milano, Milano 1, Milano 2, Oristano, Roma B, Sondrio, Trieste, Verbania and Verona.

The following are members of the BFCI Study Group, in addition to the main authors: Alessandra

Knowles, Paola Pani, Claudia Carletti (Institute for Maternal and Child Health IRCCS Burlo

Garofolo, Trieste); Annacatia Miola, Stefania Battocchio, Paola Dal Zotto (Local Health Authority,

Bassano del Grappa); Emiliana Mosca, Angelo Penna, Antonella Tedesco (Local Health Authority,

Biella); Franco Garofalo, Anna Perona (Department of Paediatrics, Biella Hospital); Paola Lenzi,

Marilina Colombo, Cledemaria Garavini (Local Health Authority, Bologna); Massimo Farneti,

Marcella Lombardi (Local Health Authority, Cesena); Anna Maria Baldoni, Laura Borghesi, Paola

Dalla Casa, Enrico Marchiani, Claudia Zoli (Local Health Authority, Forlì); Federica Braida,

Oriana Raminelli, Anna Furlan (Local Health Authority, Pordenone); Fiorella Talassi, Loretta

Grossi, Gabriele Gianella, Paola Mussini (Local Health Authority, Mantova); Rita Gatti, Grazia

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Pompilio (Maternal and Child Health Centre, Loreto); Marco Morbidoni (Department of

Epidemiology, Ancona); Mauro Tiriduzzi, Nadia Liberatore, Susi Campanari, Paola Catena

(Department of Obstetrics and Gynaecology, Osimo Hospital); Laura Polenta, Roberta Freddara

(Salesi Hospital, Ancona); Fabiola Salvetti, Cinzia Luzi, Romana Prosperi Porta (Department of

Pediatrics, Massa Carrara Hospital); Rita Mascheroni, Miriam Lelli, Graziella Cattaneo, Raffaella

Gennaretti, Antonia Tomaselli (Local Health Authority, Milan); Maria Elena Pirola, Domenico

Arensi, Giovanni Beghi, Gigliola Ronchi, Piera Ceresa, Silvano Santucci (Local Health Authority,

Milan 1); Luigi Acerbi, Maura Franzetti, Roberto Lucchini, Giuseppina De Gasperi (Local Health

Authority, Milan 2); Maria Antonietta Grimaldi (Local Health Authority, Oristano); Patrizia

Auriemma, Patrizia Proietti, Elisa Lazzaro (Local Health Authority, Rome B); Eloisa Del Curto,

Patrizia Sossi, Livia Tabacchi, Paola Abbiati (Local Health Authority, Sondrio); Maria Vittoria Sola

(Local Health Authority, Trieste); Andrea Guala, Raffaella Visentin, Luigina Boscardini, Elena

Ferzetti, Laura Cantalupi (Local Health Authority, Verbano-Cusio-Ossola); Emanuela Battisti,

Daniela Dainese, Francesca Lazzari, Elisa Pastorelli (Local Health Authority, Verona).

Contributors: AC designed and coordinated the study, participated in data analysis and

interpretation, and drafted and revised the paper. He acts as guarantor. MEB and EMC pilot tested

and developed the BFCI tools used in the study, were in charge of monitoring the implementation

of BFCI activities by gathering and analysing periodic reports from the study sites, and contributed

to the interpretation of results. AM and LCES centralized and checked all the data gathered in the

three rounds of data collection in a continuous feedback with the study sites, were in charge of

making the datasets ready for analysis, and contributed to the interpretation of results. AMM was

responsible for all the CATI interviews and prepared the relative datasets. MM carried out the

statistical analysis. All the members of the BFCI Study group participated in the implementation of

BFCI activities and in the collection of data for the first interview. All co-authors, including the

members of the BFCI Study Group, approved the final version of the manuscript.

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The manuscript’s guarantor affirms that this manuscript is an honest, accurate, and transparent

account of the study being reported; that no important aspects of the study have been omitted; and

that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Data sharing: the full dataset is available on reasonable request from the corresponding author at

[email protected]. Consent for data sharing was not obtained, but the presented data

are anonymised and risk of identification is low.

Competing interests: none declared.

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16 Pisacane A, Continisio GI, Aldinucci M, et al. A Controlled Trial of the Father's Role in

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17 Tohotoa J, Maycock B, Hauck YL, et al. Dads make a difference: an exploratory study of

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18 Baby Friendly Initiative Implementation Guidance. UNICEF UK, London, 2010

19 Baby Friendly Community Initiative: Getting Started. New Zealand Breastfeeding Authority,

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20 Breastfeeding Committee for Canada. BFI Integrated 10 Steps Practice Outcome Indicators for

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22 Bettinelli ME, Chapin EM, Cattaneo A. Establishing the Baby-Friendly Community Initiative in

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24 Macaluso A, Bettinelli ME, Chapin EM, et al. A controlled study on baby-friendly communities

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data since birth with current status data. Int J Epidemiol 2000;29:1041-6

26 Bland RM, Rollins NC, Solarsh G, et al. Maternal recall of exclusive breast feeding duration.

Arch Dis Child 2003;88:778-83


Part 1 definitions. WHO, Geneva, 2009


Part 2 measurement. WHO, Geneva, 2010

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30 ISTAT. Essere madri in Italia. ISTAT, Rome, 2007

31 ISTAT. Natalità e fecondità della popolazione residente nel 2011. ISTAT, Rome, 2012

32 Semenic S, Childerhose JE, Lauziere J, et al. Barriers, facilitators, and recommendations related

to implementing the Baby-Friendly Initiative (BFI): an integrative review. J Hum Lact

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33 Giovannini M, Riva E, Banderali G, et al. Feeding practices of infants through the first year of

life in Italy. Acta Paediatr 2004;93:492-7

34 Giovannini M, Banderali G, Agostoni C, et al. Epidemiology of breastfeeding in Italy. Acta

Paediatr Suppl 1999;88:19-22

35 Pirola ME, Bettinelli ME, Bonfanti M, et al. Prevalenza, esclusività e durata dell'allattamento al

seno in Regione Lombardia. Regione Lombardia, Milano,

36 Marchetti F. Prevalenza dell'allattamento al seno e altri interventi preventivi in Emilia Romagna.

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37 Cattaneo A, Giuliani C. Breastfeeding in Friuli Venezia Giulia. Eur J Public Health 2006;16:111

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38 Cuoghi C, Di Mario S, Borgini B, et al. Prevalenza dell'allattamento al seno e altri interventi

preventivi in Emilia-Romagna. Regione Emilia Romagna, Bologna, 2011

39 ISTAT. Gravidanza, parto e allattamento al seno, anno 2013. ISTAT, Rome, 2014

40 Schmied V, Gribble K, Sheehan A, et al. Ten steps or climbing a mountain: a study of Australian

health professionals' perceptions of implementing the baby friendly health initiative to protect,

promote and support breastfeeding. BMC Health Serv Res 2011;11:208

41 Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to

improve health care. BMJ 2007;334:455-9

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Figures’ titles

Figure 1. A sketch of the study design.

Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round

of data collection.

Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round

of data collection.

Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of

data collection.

Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data

collection.

Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data

collection.

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Figure 1. A sketch of the study design. 76x59mm (300 x 300 DPI)

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Figure 2. Rates of exclusive breastfeeding at discharge (recall from birth) by site, group and round of data collection.

54x36mm (300 x 300 DPI)

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Figure 3. Rates of exclusive breastfeeding at three months (recall 7 days) by site, group and round of data collection.

54x32mm (300 x 300 DPI)

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Figure 4. Rates of exclusive breastfeeding at six months (recall 7 days) by site, group and round of data collection.

54x36mm (300 x 300 DPI)

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Figure 5. Rates of any breastfeeding at six months (recall 24 hours) by site, group and round of data collection.

54x36mm (300 x 300 DPI)

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Figure 6. Rates of any breastfeeding at 12 months (recall 24 hours) by site, group and round of data collection.

54x36mm (300 x 300 DPI)

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Appendix

Table A1. Subjects enrolled and followed up to 12 months by LHA in the early and late intervention groups and by round of data collection

Group LHA Assigned

sample

size

Round 1

(01/09/09-31/03/10)

Round 2

(01/09/10-31/03/11)

Round 3

(01/09/11-31/03/12)

Total

Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss Enrolled F-up

12 m

Loss

Early

interv

ention

5 124 124 103 17% 126 115 9% 129 116 10% 379 334 12%

6 48 48 38 21% 47 43 9% 47 42 11% 142 123 13%

8 54 56 52 7% 61 55 10% 58 50 14% 175 157 10%

9 121 122 99 19% 122 93 23% 123 105 15% 367 297 19%

10 109 109 91 17% 112 105 5% 113 99 12% 334 295 12%

14 122 120 96 20% 117 102 13% 122 109 11% 359 307 14%

15 126 126 117 7% 127 111 13% 126 107 15% 379 335 12%

16 134 134 121 10% 135 122 10% 134 119 11% 403 362 10%

18 103 103 81 21% 103 94 9% 103 89 14% 309 264 15%

Total 942 942 798 15% 949 840 11% 955 836 12% 2846 2474 13%

Late in

tervention

1 136 139 117 16% 142 125 12% 140 122 13% 421 364 14%

2 85 94 77 18% 101 92 9% 100 88 12% 295 257 13%

3 50 51 37 27% 49 42 14% 47 40 15% 147 119 19%

4 143 147 131 11% 142 133 6% - - - 289 264 9%

7 115 129 101 22% - - - 130 118 9% 259 219 15%

11 62 61 54 11% 61 49 20% 62 53 15% 184 156 15%

12 68 68 56 18% 67 52 22% 69 55 20% 204 163 20%

13 43 53 50 6% 53 43 19% 51 43 16% 157 136 13%

17 97 97 89 8% 98 80 18% 97 84 13% 292 253 13%

Total 799 839 712 15% 713 616 14% 696 603 13% 2248 1931 14%

Grand total 1741 1781 1510 15% 1662 1456 12% 1651 1439 13% 5094 4405 14%

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Table A2. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by early and late

intervention groups and round of data collection. Late intervention group at round 1 of data collection as comparator. Statistically significand

differences (p<0.05) in bold.

Breastfeeding

indicators

Round of

data

collection


AR

(%)

95% CI

(%)

OR 95% CI AR

(%)

95% CI

(%)

OR 95% CI

EBF at

discharge

(recall 24 h)

1 87.2 83.4-91.1 1.03 0.62-1.70 86.9 82.7-91.1 1 -

2 88.4 84.8-92.1 1.15 0.69-1.91 85.6 80.9-90.2 0.89 0.61-1.31

3 87.4 83.5-91.3 1.04 0.63-1.74 86.4 82.0-90.8 0.96 0.65-1.40

EBF at

discharge

(from birth)

1 72.2 62.0-82.5 1.36 0.66-2.76 65.7 54.0-77.5 1 -

2 73.6 63.6-83.6 1.45 0.71-2.96 70.2 59.1-81.2 1.23 0.90-1.67

3 73.1 63.0-83.2 1.41 0.69-2.89 73.5 63.3-83.8 1.45 1.05-1.99

EBF at 3

months

(recall 24 h)

1 57.7 52.6-62.8 1.13 0.86-1.49 54.7 49.2-60.2 1 -

2 57.1 51.9-62.3 1.10 0.83-1.45 54.5 48.8-60.2 0.99 0.79-1.25

3 61.8 56.8-66.9 1.34 1.01-1.77 58.1 52.4-63.7 1.15 0.90-1.46

EBF at 3

months

(recall 7 d)

1 48.6 42.9-54.3 1.13 0.82-1.55 45.6 39.7-51.6 1 -

2 52.0 46.3-57.7 1.29 0.94-1.78 51.4 45.2-57.6 1.26 1.00-1.58

3 54.9 49.2-60.6 1.45 1.05-2.00 51.4 45.1-57.6 1.26 0.99-1.59

EBF at 6

months

(recall 24 h)

1 8.6 5.6-11.7 1.17 0.67-2.05 7.4 4.6-10.3 1 -

2 7.3 4.6-9.9 0.98 0.55-1.71 8.3 5.1-11.5 1.13 0.77-1.65

3 7.3 4.6-9.9 0.97 0.55-1.71 9.3 5.8-12.8 1.27 0.86-1.87

EBF at 6

months

(recall 7 d)

1 5.2 3.0-7.3 0.93 0.50-1.73 5.5 3.2-7.9 1 -

2 5.2 3.1-7.3 0.93 0.50-1.72 6.7 3.9-9.5 1.22 0.80-1.84

3 5.0 2.9-7.1 0.90 0.49-1.66 7.1 4.1-10.0 1.30 0.85-1.98

ABF at 6

months

(recall 24 h)

1 67.8 63.1-72.6 1.18 0.94-1.48 64.1 58.9-69.3 1 -

2 66.9 62.1-71.7 1.13 0.90-1.42 63.7 58.3-69.1 0.98 0.77-1.24

3 69.1 64.4-73.8 1.25 0.99-1.57 66.5 61.2-71.9 1.11 0.87-1.42

ABF at 12

months

(recall 24 h)

1 32.0 27.2-36.8 1.12 0.86-1.45 29.7 24.8-34.5 1 -

2 34.8 29.9-39.6 1.26 0.98-1.63 31.1 26.0-36.2 1.07 0.84-1.37

3 35.9 31.0-40.9 1.33 1.03-1.72 34.8 29.4-40.1 1.26 0.98-1.62

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Table A3. Adjusted rates of breastfeeding (AR) and odd ratios (OR), with their respective 95% confidence intervals (95% CI), by compliance with the

intervention and round of data collection. Non-compliance group at round 1 of data collection as comparator. Statistically significand differences

(p<0.05) in bold.

Breastfeeding

indicators

Round of

data

collection


AR

(%)

95% CI

(%)

OR 95% CI AR

(%)

95% CI

(%)

OR 95% CI

EBF at

discharge

(recall 24 h)

1 87.2 83.5-90.8 1.02 0.60-1.75 86.9 82.1-91.8 1 -

2 86.9 83.2-90.6 0.99 0.58-1.70 88.0 83.3-92.7 1.10 0.71-1.71

3 87.9 84.4-91.4 1.09 0.64-1.88 84.9 79.5-90.3 0.85 0.55-1.30

EBF at

discharge

(from birth)

1 70.3 60.4-80.2 1.16 0.53-2.50 67.2 53.9-80.5 1 -

2 69.6 59.6-79.6 1.12 0.52-2.41 76.2 64.9-87.4 1.56 1.09-2.23

3 72.2 62.7-81.7 1.27 0.59-2.75 74.5 62.9-86.0 1.42 1.00-2.04

EBF at 3

months

(recall 24 h)

1 60.5 56.9-64.2 1.64 1.26-2.13 48.3 43.3-53.4 1 -

2 58.3 54.6-62.0 1.49 1.15-1.93 51.4 46.1-56.7 1.13 0.88-1.46

3 63.4 59.9-67.0 1.85 1.43-2.41 54.6 49.4-59.8 1.28 0.99-1.67

EBF at 3

months

(recall 7 d)

1 50.4 45.7-55.1 1.42 1.03-1.95 41.8 35.8-47.8 1 -

2 53.4 48.7-58.0 1.60 1.16-2.19 48.8 42.4-55.2 1.33 1.03-1.72

3 56.2 51.6-60.9 1.79 1.30-2.46 48.5 42.1-54.8 1.31 1.01-1.71

EBF at 6

months

(recall 24 h)

1 9.6 6.6-12.5 1.67 0.93-3.01 5.9 3.3-8.6 1 -

2 8.1 5.5-10.6 1.38 0.77-2.49 7.7 4.3-11.0 1.31 0.83-2.08

3 9.2 6.3-12.0 1.60 0.89-2.88 6.4 3.5-9.3 1.08 0.66-1.76

EBF at 6

months

(recall 7 d)

1 6.1 3.8-8.3 1.39 0.72-2.67 4.4 2.2-6.7 1 -

2 6.1 3.8-8.3 1.39 0.73-2.67 5.8 2.9-8.7 1.32 0.80-2.19

3 6.7 4.3-9.2 1.55 0.81-2.98 4.5 2.1-6.8 1.01 0.59-1.73

ABF at 6

months

(recall 24 h)

1 68.7 64.5-72.9 1.40 1.07-1.84 61.0 55.4-66.6 1 -

2 67.3 63.0-71.5 1.31 1.01-1.71 61.7 55.9-67.5 1.03 0.79-1.34

3 70.1 66.0-74.3 1.50 1.15-1.97 64.0 58.4-69.6 1.14 0.87-1.48

ABF at 12

months

(recall 24 h)

1 33.0 28.6-37.4 1.31 0.97-1.76 27.3 22.2-32.5 1 -

2 35.0 30.5-39.4 1.43 1.07-1.92 29.8 24.3-35.4 1.13 0.86-1.50

3 37.2 32.6-41.7 1.57 1.17-2.11 32.5 26.9-38.2 1.28 0.96-1.71

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