human milk banking: an indian experience · 4/16/2018  · retinopathy of prematurity † human...

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Human Milk Banking: An Indian Experience Sushma Nangia, MD, DM (Neonatology),* Ruchika Chugh Sachdeva, MS (Nutrition), Vandana Sabharwal, MS, PhD (Nutrition) *Department of Neonatology, Lady Hardinge Medical College & Kalawati Saran Childrens Hospital, New Delhi, India Maternal, Newborn, Child Health and Nutrition, PATH India, New Delhi, India Institute of Home Economics, Delhi University, New Delhi, India Education Gaps 1. There is a scarcity of systematic data on human milk banking practices in India. 2. The role of policy and technical leaders in promoting human milk banking as part of an integrated approach in optimizing neonatal health needs to be understood. Abstract As part of integrated newborn care, human milk banks can reduce death and illness as well as lower health-care costs for infants born prematurely, especially with birthweights less than 1,500 g, and for infants born in resource-limited settings without access to their mothers milk. Promotion of human milk banks is of special signicance in India which has the highest burden of such infants. About 50 milk banks are insufcient to meet the needs of vulnerable infants. The government of India has acknowledged the role that human milk banking can play in reducing neonatal mortality and morbidity, and launched the National Guidelines on Lactation Management Centers in Public Health Facilitiesin 2017 with a vision to make breast milk universally available for all infants. The government is now working on an implementation strategy to scale up the lactation management center model (promotion of breastfeeding, kangaroo mother care, and donor human milk) for all newborn care units and delivery centers in the country. However, for effective expansion, it will be important to ensure improved government ownership, mandate availability of standard operating procedures at all facilities, stringent systems of quality control, standardized accreditation, and a robust monitoring system. Local evidence on the effectiveness of the comprehensive lactation management center (CLMC) model and knowledge, practices, and perceptions of human milk banking are limited. There is a need for rigorous implementation, process research, and technology innovation, along with a robust regulatory framework to prevent commercialization. In addition, attitude changes of mothers, maternal inuencers, and health-care providers are all essential to successfully expand the CLMC model. AUTHOR DISCLOSURE Drs Nangia and Sabharwal and Ms Sachdeva have disclosed no nancial relationships relevant to this article. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device. ABBREVIATIONS CLMC Comprehensive Lactation Management Center LMU lactation management unit LSU lactation support unit MAA mothers absolute affection MOM mothers own milk MBFIþ Mother Baby Friendly Initiative Plus NMR neonatal mortality rate Vol. 19 No. 4 APRIL 2018 e201 International Perspectives by guest on April 2, 2018 http://neoreviews.aappublications.org/ Downloaded from

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Page 1: Human Milk Banking: An Indian Experience · 4/16/2018  · Retinopathy of prematurity † Human milk feeding in the NICU is associated with lower rates of severe retinopathy of prematurity

Human Milk Banking: An Indian ExperienceSushma Nangia, MD, DM (Neonatology),* Ruchika Chugh Sachdeva, MS (Nutrition),† Vandana Sabharwal, MS, PhD

(Nutrition)‡

*Department of Neonatology, Lady Hardinge Medical College & Kalawati Saran Children’s Hospital, New Delhi, India†Maternal, Newborn, Child Health and Nutrition, PATH India, New Delhi, India

‡Institute of Home Economics, Delhi University, New Delhi, India

Education Gaps

1. There is a scarcity of systematic data on human milk banking practices in

India.

2. The role of policy and technical leaders in promoting human milk banking

as part of an integrated approach in optimizing neonatal health needs to

be understood.

Abstract

As part of integrated newborn care, humanmilk banks can reduce death and

illness as well as lower health-care costs for infants born prematurely,

especially with birthweights less than 1,500 g, and for infants born in

resource-limited settings without access to their mother’s milk. Promotion of

human milk banks is of special significance in India which has the highest

burden of such infants. About 50 milk banks are insufficient to meet the

needs of vulnerable infants. The government of India has acknowledged the

role that human milk banking can play in reducing neonatal mortality and

morbidity, and launched the “National Guidelines on Lactation Management

Centers in Public Health Facilities” in 2017 with a vision to make breast milk

universally available for all infants. The government is now working on an

implementation strategy to scale up the lactationmanagement centermodel

(promotion of breastfeeding, kangaroo mother care, and donor human milk)

for all newborn care units and delivery centers in the country. However, for

effective expansion, it will be important to ensure improved government

ownership, mandate availability of standard operating procedures at all

facilities, stringent systems of quality control, standardized accreditation, and

a robust monitoring system. Local evidence on the effectiveness of the

comprehensive lactationmanagement center (CLMC)model and knowledge,

practices, and perceptions of humanmilk banking are limited. There is a need

for rigorous implementation, process research, and technology innovation,

along with a robust regulatory framework to prevent commercialization. In

addition, attitude changes of mothers, maternal influencers, and health-care

providers are all essential to successfully expand the CLMC model.

AUTHOR DISCLOSURE Drs Nangia andSabharwal and Ms Sachdeva have disclosedno financial relationships relevant to thisarticle. This commentary does not contain adiscussion of an unapproved/investigativeuse of a commercial product/device.

ABBREVIATIONS

CLMC Comprehensive Lactation

Management Center

LMU lactation management unit

LSU lactation support unit

MAA mother’s absolute affection

MOM mother’s own milk

MBFIþ Mother Baby Friendly Initiative Plus

NMR neonatal mortality rate

Vol. 19 No. 4 APR IL 2018 e201

International Perspectives

by guest on April 2, 2018http://neoreviews.aappublications.org/Downloaded from

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Objectives After completing this article, readers should be able to:

1. Describe how prioritizing an integrated approach in human milk banking

can save lives in India.

2. Recognize the salient features of the national guidelines on human milk

banking along with the human milk banking environment in India.

3. Outline key initiatives to be addressed for effective scaling up of human

milk banking in India.

THE POWER OF HUMAN MILK

Breastfeeding is the most natural, inexpensive, environment-

friendly, and easily accessible method to provide all children,

rich or poor, with thehealthiest start to life and ensures that all

children survive and thrive. Breastmilk offers the ideal source

of nutrition for thefirst 6months after birth, andmay remain

a part of an infant’s diet for thefirst 2 years of age and beyond.

(1) There is evidence that demonstrates the value of breast-

feeding for both a mother and her child. Sushruta, an ancient

Indian surgeon, has beautifully described mother’s milk in

his Samhita, “One just cannot compare even water of seven

seas with mother’s milk, which is nothing but water ensur-

ing optimum growth, nutrition, and healthy life of hundred

years.” (2)

However, many infants lack access to their mother’s own

milk (MOM) because of issues related to the mother’s illness

or death, abandonment, infant’s illness, inability to latch, or

delay in milk production. This lack of access to breast milk

leaves infants more vulnerable to disease, poor health, or

death, especially when they are born preterm, have low

birthweight, or are severely malnourished. (3)(4)(5) In such

a scenario, the World Health Organization, (6) American

Academy of Pediatrics, (7) the Committee on Nutrition

of the European Society for Pediatric Gastroenterology,

Hepatology, and Nutrition, (8) and other policy groups

recommend donor human milk, made available through

human milk banks, as the next best feeding option when

MOM is unavailable. A human milk bank screens and

recruits breast milk donors; collects, processes, and screens

donated milk; and distributes the milk to infants in need.

As part of integrated newborn care, human milk banks

reduce death and illness as well as lower health-care costs.

Data exist, which support the health benefits of donor

human milk, especially for infants born prematurely, with

birthweight less than 1,500 g, (9) and for infants born in

resource-limited settings where a non-breastfed child’s risk

of death is 6 times that of a breastfed child. (10) A myriad

studies demonstrate the positive effect of donor human

milk on vulnerable infants as compared with formula, such

as reduced risk of sepsis and necrotizing enterocolitis, greater

feeding tolerance, reduced length of stay in NICUs, and sub-

stantial cost savings for resource-strapped public health sys-

tems (Table 1). (8)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)

(23)(24)(25)(26)

A recent study found that if all premature infants born in

the United Kingdom in 2013 were provided with mother’s

milk in the NICU, the total lifetime cost savings to the

National Health Systemwould be an estimated $46.7 million

(£30.1 million in the first year) as a result of improved health

outcomes. The total lifetime quality-adjusted life-year gain

was calculated to be 10,594 years. There would be 238 fewer

deaths caused by neonatal infections and sudden infant death

syndrome, leading to a savings of approximately £153.4

million in lifetime productivity. (27)

Providing donor human milk to vulnerable neonates

without access toMOMnot only saves lives but also enhances

awareness about breastfeeding and improves breastfeeding

rates. This increase in breastfeeding rates is important

because it has the potential to prevent 820,000 “under-5”

deaths (ie, death before age 5 years), of which 87% are

infants younger than 6 months of age. (28) Improving

breastfeeding rates worldwide is a fundamental driver to

achieve Sustainable Development Goals by 2030.

HUMAN MILK BANKING: A CENTURY-OLD PRACTICE

Saving infants with the use of donor human milk through

human milk banks is a century-old practice. Countries in

North America and Europe established human milk banks

in the early 20th century. The United Kingdom established

its first human milk bank in the 1930s, and Brazil in the

1940s. Today, more than 600 milk banks have been estab-

lished in more than 50 countries. Human milk banks have

been extremely successful in Brazil, its network being the

largest in the world with 213 milk banks and 199 collection

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centers. The Brazilian Network of HumanMilk Banking has

successfully demonstrated the effectiveness of a government-

supported, nationalized, integrated human milk bank pro-

gram that includes breastfeeding promotion, lactation

support, and provision of donor milk, all of which have

contributed to achieving a single-digit neonatal and infant

mortality rate. Brazil’s integrated human milk banking pro-

gram saves the country an estimated $540 million annually

through improved neonatal health outcomes. (29)

PRIORITIZING AN INTEGRATED APPROACH FORHUMAN MILK BANKING IN INDIA

India faces its own unique challenges. The country is the

highest contributor to the global birth cohort, neonatal

mortality rate, and birth of vulnerable infants, that is, infants

born prematurely and with low birthweight. Of the 27

million infants born in India annually, 30% are born with

low birthweight (ie, weighing<2,500 g), and 40% of all low-

birthweight infants (estimated at 3.5 million infants), are

born preterm (Fig 1). (30) Of the 0.76 million infants who

die in the neonatal period, prematurity is the major cause,

accounting for 35% of all deaths, followed by infection,

accounting for another 33%. (30)

India hasmade considerable progress over the last 2decades

in the area ofmaternal and child health through innovative and

comprehensive health packages that cover the spectrum of

life cycle stages. However, newborns have missed out on the

attention. Even though the under-5 mortality rate decreased by

42%, from74 (in 2005–06) to 43 (in 2015) per 1,000 live births,

in the same period, neonatal mortality rate (NMR) decreased

from 37 to 25 per 1,000 live births, accounting for a decrease of

only 32%. (31)(32) This decline in NMR is laudable but it has to

increase to effectively achieve sustainable development goals,

which aim to eliminate preventable deaths of children less than

5 years of age, with all countries aiming to decrease theNMR to

as low as 12 per 1,000 live births. (33)

About 75% of premature infants can be saved with

feasible and cost-effective interventions. These include kan-

garoo mother care; adequate neonatal resuscitation; pre-

vention, detection, and treatment of neonatal infections; and

breastfeeding. (34) Of these, breastfeeding has been iden-

tified as the single most powerful intervention, with the

potential to prevent 0.16 million under-5 deaths in India.

(28) Yet, breastfeeding rates remain low, with only 41.6% of

infants being initiated into breastfeeding within 1 hour of

birth and 54.9% of infants exclusively breastfed until 6

months of age. (35)

TABLE 1. Studies Demonstrating the Impact of Donor Human Milk onVulnerable Infants

Sepsis • Donor human milk reduced the risk of late-onset sepsis in vulnerable, low-birthweight infants by19% in the first 28 days. (11)

• Donor human milk has a greater protective effect compared with formula. (12)

Necrotizing enterocolitis • Human milk feeding, whether mother’s own milk or donor human milk reduces necrotizingenterocolitis by as much as 79% when formula is avoided. (13)

• Four systematic reviews across study designs and countries found that donor human milk protectspreterm infants against necrotizing enterocolitis more than formula. (8)(14)(15)(16)

Retinopathy of prematurity • Human milk feeding in the NICU is associated with lower rates of severe retinopathy of prematurity.(17,18)

Feeding tolerance • Preterm infants fed unfortified donor human milk had greater feeding tolerance, fewer vomits, lessgastric stasis, and reduced diarrhea compared with formula-fed infants. (16)

Reduced length of stay in NICU • Cost of providing donor human milk to preterm infants is mitigated by a reduced risk ofcomplications and shorter length of stay in NICU. (11)(19)

• Fewer hospital readmissions for illness in the year after NICU discharge have been noted. (20)

Cost saving • The percentage of infants who are exclusively breastfed at discharge is about 13% higher in NICUswith a human milk bank. (21)

• A study reported savingwUS $8,167 per infant using donor humanmilk through shortened length ofstay and reduced cases of necrotizing enterocolitis and sepsis. (19)

• Estimated savings to NICU or health care plan for every dollar spent ondonor humanmilk:wUS$11. (22)• In Brazil, the national humanmilk banking network saves $540 million in health care costs annually. (23)

Neurodevelopmental outcomes andlong-term benefits

• Later in childhood and adulthood, preterm infants fed human milk have been shown to have lowerrates of metabolic syndrome, (24)(25) increased white matter and brain volume, and significantlygreater scores for mental, motor, and behavior ratings. (19)(26)

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Breastfeeding has a pertinent and important role to play

in improving the status of neonatal health in India. This

emphasizes the need to universalize access to human milk

as an integral component in the country’s health-care sys-

tem, especially in all newborn units that provide care to sick

infants. Providing human milk through human milk

banks can work only if it is a part of the larger objective

of promoting breastfeeding. There is a need to link human

milk banking systems with breastfeeding and kangaroo

mother care by establishing high-quality systems, sharing

global best practices, and facilitating capacity building. An

integrated intervention will not only assist in feeding human

milk to preterm and low-birthweight infants, but will also

increase breastfeeding rates in the country. Previous experi-

ence shows that humanmilk banks thrive in countries where

they are protected, promoted, and endorsed as a critical com-

ponent of breastfeeding and newborn care policies. (29)

Based on its existing toolkit on the establishment of

humanmilk banks, “StrengtheningHumanMilk Banking:

A Global Implementation Framework,”(36) PATH has

proposed the “Mother Baby Friendly Initiative Plus”

(MBFIþ) model in which human milk banks collect, pro-

cess, and store donor human milk while serving as centers

that provide lactation and kangaroo mother care support.

(29) Because successful breastfeeding often requires

support from the family and community, the model also

positions human milk banks to work with and engage

local communities. These banks promote the significance

of breastfeeding and milk donation, build awareness about

the value of human milk, and collaborate with employers

and other leaders to create an enabling and supportive

environment for breastfeeding and milk donation. (36)

The MBFIþmodel is deliberately intended to be altered by

each country to fit its unique needs. Similarly, the model has

been adapted to suit India’s public health structure (Fig 2).

HUMAN MILK BANKING LANDSCAPE IN INDIA

In India, voluntary donation of human milk in the form of

wet nursing has been an integral part of its tradition.

Mythological anecdotes tell tales of Yashoda, who was a wet

nurse (human milk donor) to Lord Krishna. In the 18th

century, wet nursing was widely practiced for offspring of

mothers born into nobility who refused to breastfeed their

infants to preserve their beauty and figure. Later, the practice

declined because of a fear of transfer of infections and

diseases such as syphilis. Much later, the concept of human

milk banks was introduced.

In Asia, the first human milk bank was established

in 1989 by Dr Armida Fernandez in Lokmanya Tilak

Municipal Medical College and General Hospital, Mumbai,

India. The milk bank was started after realizing the acute

need to save sick infants in hospitals. It soon became

sustainable as mothers who had delivered at the hospital

and donated milk to the milk bank returned for follow-up

care. (37) Despite the successful establishment of this bank,

other hospitals were not encouraged to take up this venture

and this remained the only humanmilk bank in the country

until the year 2005. From 2005 to 2015, only 22 humanmilk

banks were established, but in the past 2 years, this number

has more than doubled. There are currently about 50 milk

banks in India, which are still inadequate to meet the massive

demand for donor human milk (Fig 3). To put this in per-

spective, the United Kingdom has 770,000 births each year

and 16 operational milk banks, whereas India has 27 million

births each year and only 50 operational milk banks.

Historically, implementation of effective regulated, coun-

try-specific, humanmilk banks have been slow to develop in

India. Initially, human milk banks were concentrated in the

western belt of the country because the first human milk

bank was established in this region, and themajority of milk

banks were modeled on this first one. The development of

milk banks has met with several challenges including

inadequate collaboration between obstetricians and pedia-

tricians, lack of lactation counselors, and limited awareness.

(37) There are also gaps in providing able leadership for

sharing best practices and robust procedures. However, the

changing landscape has facilitated an expansion in human

milk banks in some parts of the country.

INDIA-SPECIFIC STUDIES ON HUMAN MILK BANKING

A recent study conducted to understand current practices,

processes, infrastructure, personnel structure, and funding

mechanisms in human milk banks with minimum 1 year

of functioning (n¼16) revealed that standardization of

processes as well as data capturing and reporting were

urgently needed. (38) Only 25% of the study sites pooled

milk under laminar airflow. Sixty-two percent of the facilities

used steel containers for milk pasteurization and storage,

which is unique to India. Because steel is widely used in

homes and laboratories and has good conductivity, it results

in faster heating and cooling cycles. This helps preserve

milk nutrients better, especially its sensitive immunologic

components, because the duration of exposure to extremes

of temperature is curtailed. Steel can be easily cleaned and

sterilized by exposure to dry heat in a normal oven, there-

fore, it has been an obvious choice of milk banks in India.

Only 50%ofmilk banks had dedicated full-time technicians.

In the remainingmilk banks, lactation counselors and other

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staff managed the processes. Only 31% of milk banks had

3 or more dedicated lactation counseling staff; thus, the

shortage of staff has been a stumbling block. Most of the

milk banks pooled donor milk from multiple mothers. All

the facilities used the Holder method of pasteurization.

Processed donor human milk was used within a week or

fortnight because of high demand in most of the sites. Milk

collection was between 3 and 6 L every day in most of the

facilities. The majority of milk banks reported a significant

demand-supply gap. Hence, as a step to help mitigate the

demand, select sites have recently developed satellite milk

collection centers. The need to discard samples because of

the presence of microbes after pasteurization was less than

5% at most study sites. (38)

Milk is predominantly collected at the facility level with

one-third of the sites collectingmilk from camps and homes

as well. Donor milk collection in India is mainly from

mothers of preterm infants, hospitalized mothers after

delivery, andmothers who visit pediatric clinics for pediatric

immunizations. These mothers are mostly cross-sectional

donors. Longitudinal donation is not yet practiced in India.

Even home-based collection ofmilk is not common and very

few hospitals promote it. (38) Education for safe collection is

imperative for home-based collection because of the poten-

tial risks of voltage fluctuations and electricity failures.

Only in-facility dispensation of donor human milk is

promoted and once the infant goes home, there is no source

of continuing humanmilk feeding if themother cannot feed

her child. (38)

Nearly 85%ofmilk banks in India have been establishedby

nongovernment organizations, and only a handful had been

supported by the government. (38) However, within the last

2 years nearly 50% of milk banks have been supported by the

state governments. Rajasthan, one of the states with a high

neonatal mortality rate, has supported the setting up of 10 milk

banks during the last year. Similarly, the state government of

Tamil Nadu has supported setting up 7 milk banks. The recur-

ring cost ofmostmilkbanks ismanaged throughhospital funds.

Various socioeconomic factors influence maternal moti-

vation and willingness to donate breast milk. Katke and

Saraogi reported that women at either end of the reproduc-

tive age spectrum and women with higher parity require

more motivation to donate breast milk. Furthermore,

milk donation can be promoted in India by teaching women

about the benefits of donor milk. (39) A recent study sur-

veyed mothers and influencers (fathers and grandmothers)

about barriers to breastfeeding, kangaroo mother care, and

providing donor humanmilk to preterm and sick neonates in

India. (40) This study found limited awareness about human

milk banks among mothers and influencers. Parents were

Figure 1. Overview of newborn health in India compared to global statistics.

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supportive about donating milk once they learned that it was

life-saving and did not compromise the supply to their own

infant. However, some parents had safety concerns about the

use of donor humanmilk andwere not aware ofmilk banking

processes. Most grandmothers were not comfortable with

having their daughters/daughters-in-law donate milk or hav-

ing their grandchild receive donor milk because they felt it

may hinder supply for their grandchild. Mostmothers shared

that physicians counseled them about their dietary intake

during antenatal care, but did not provide them with infor-

mation about breastfeeding. Few mothers shared the chal-

lenges they faced with feeding their preterm and sick infants.

Mothers who practiced kangaroo mother care were aware of

its benefits. Respondents shared that wet nursing is an old

practice. They found wet nursing to be helpful, as the infant

receives human milk and they are assured that it is not

harmful for the infant if practiced within the family. (40)

ROLE OF THE GOVERNMENT IN SCALING UP HUMANMILK BANKING IN INDIA

The government of India has acknowledged the role that

human milk banking can play in reducing neonatal mor-

tality and morbidity and held the first national consultative

meeting for formulating national guidelines on human

milk banking in 2013. Subsequently, the Indian Academy

of Pediatrics formulated a set of guidelines in 2013. (41)

The government of India highlighted the need for formu-

lating operational guidelines with robust protocols and empha-

sis on implementation strategy, quality control mechanisms,

monitoring, and accreditation. The Ministry of Health and

Family Welfare took this initiative in 2014 and formed a group

composed of human milk bank experts, neonatologists, regu-

latory officials, and quality and public health specialists to

support this effort. Subsequently, the government launched

the “National Guidelines on LactationManagement Centers in

Public Health Facilities” in July 2017. (42) These guidelines

are part of a program focusing on breastfeeding launched by

the government of India called Mother’s Absolute Affection

(MAA). MAA in Hindi, the national Indian language, means

mother. The vision of the government is to make breast

milk universally available for all infants by establishing

comprehensive lactation management centers (CLMC),

lactation management units (LMUs) and lactation support

units (LSUs) at the facility level. The CLMCmodel is based

on the MBFIþ model (Fig 4).

Themodel builds on India’s public health systemwhich is

a 3-tier system with primary, secondary, and tertiary levels of

care. The district hospital is an essential component of the

district health system and provides secondary level of care.

Every district has a hospital that is linked to health facilities

under the district such as subdistrict hospitals, community

health centers, primary health centers, and health subcenters.

Primary health centers are the cornerstone of rural health

Figure 2. Mother Baby Friendly Initiative Plus model adapted for India’s health structure. (Adapted from reference 36.)

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services, providing basic essential newborn care. They cater to

a population of around 30,000 with the help of a medical

officer, pharmacist, and support staff. Community health

centers, catering to a population of 120,000 people, are the

first level where specialists are available. They aim to provide

secondary level care with stabilization services for newborns.

First referral units are being developed by upgrading selected

community health centers and subdistrict hospitals where

24-hour emergency obstetric and child health services will

be provided. (43) Currently, there are 715 functional special

care newborn units, mostly at district hospitals, to reduce

case fatality among sick newborns and to function as

training centers for teaching newborn care skills. A large

number of secondary and tertiary care units responsible

for newborn care are usually within larger hospitals, many

even higher than the district level such as at the medical

college level.

SALIENT FEATURES OF THE NATIONAL GUIDELINES

LMCs are seen as an effort to promote the natural act of

breastfeeding and ensure availability of safe donor human

milk for sick infants when MOM is not available. A CLMC

will be set up at tertiary care facilities/medical colleges

with a functional NICU and high delivery load. This would

function as a lactation support center to support breastfeed-

ing, as well as to safely collect, process, and provide safe

donor human milk. Subsequently, CLMCs will be set up at

Figure 3. States with operational human milk banks in India.

Figure 4. Facility based lactation management at the three levels.(Reprinted from reference 42.)

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district hospitals that fulfill the prerequisites for establish-

ing one. These units will support breastfeeding mothers,

encourage kangaroo mother care, and support the forma-

tion of LMUs at first referral units/subdistrict hospitals.

These LMUs will facilitate the expression and collection of

MOM for her infant’s use. To maintain the continuum of

care, LSUs will be established at all delivery points by

forming a dedicated team of staff trained to provide round-

the-clock breastfeeding support, lactation counseling, and

kangaroo mother care support to mothers. (42)

The guidelinesmandate informed consent by both the donor

and the recipient. Donor milk will only be dispensed with a

physician’s prescription and is recommended tomeet the short-

and long-term needs of newborns admitted in NICUs/sick

newborn care units with the following conditions: 1) pre-

maturity, 2) low birthweight, 3) malabsorption, and 4) feed-

ing intolerance.

Donating humanmilk will be a completely voluntary and

nonincentivized activity, and this milk cannot be used for

any commercial purposes. The government is working on

developing a regulatory mechanism to prevent human milk

commercialization.

Human milk donation and dispensation will be done

only at specialized units within the CLMC with the highest

regard for safety and meticulous approach to ensuring

quality. The guidelines consist of evidence-based and

standardized technical protocols for donor screening

and collection, processing, storage, and dispensation of

human milk. Ensuring the quality and safety of donor

human milk is an important component of these guide-

lines. In addition, recommendations have been made to

minimize the risk of donor human milk to recipients. The

standards of quality have been stated in detail with a strong

focus on hygiene and handling of milk. The guidelines

enforce mandatory training of staff on a Hazard Analysis

Critical Control Points system, which is a management

system designed to address food safety from production to

consumption.

A National Human Milk Bank has been established

which will function as the national resource center to pro-

vide training, undertake quality audits, and ensure technical

support to establish new CLMCs and LMUs. Regional and

zonal reference centers will be established in each geo-

graphical zone at well-performing CLMCs, to assist the

TABLE 2. Suggested Initiatives for Technical and Policy Leaders to ImproveAccess to Human Milk

Improve government ownership to meet recurring costs, address personnel shortages, and enhance community mobilization.

Mandate availability of standard operating procedures at facilities for uniform process implementation and to ensure safety.

Establish one national and few zonal reference centers to develop stringent systems for monitoring and evaluation, accreditation and quality control.

Develop a strong regulatory framework and effectively implement the same to prevent commercialization.

Generate local evidence on the CLMCmodel by undertaking research to determine knowledge, practices, and perceptions related to the establishmentof CLMCs in similar community settings and to explore the multidimensional aspects in opportunities and challenges for scaling up human milkbanking in India.

Develop robust behavior change communication strategies related to breastfeeding, kangaroo mother care, and donor human milk targetedat mothers and influencers, starting from the antenatal period.

Provide skill-based training to medical practitioners and health care providers on the CLMC model.

Ensure counseling of pregnant women and lactating mothers by health-care providers and peer educators to promote early initiation of breastfeedingin the labor room.

Use mother support groups to create a suitable environment for continued and sustained breastfeeding.

Slowly eliminate wet nursing, an ancient and deep-rooted practice, by generating intensive awareness about its adverse effects.

Establish satellite centers attached to milk banks to recruit more donors to benefit more infants.

Extend the guidelines to the private sector to ensure that infants born in the private sector (about 60% rural and 70% urban areas) are also covered. (44)

Gather technical and policy leaders to discuss steps to ensure access to donor human milk for all infants in need whether in the hospital or at home.

Develop technologies that improve quality systems and are easy to use and cost-effective to help humanmilk banks run safely and effectively not only inIndia but other low-resource settings around the globe.

CLMC¼Comprehensive lactation management center.

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national resource center by serving as a technical resource

for nearby CLMCs, LMUs and LSUs. (42)

THE WAY FORWARD

Some noteworthy initiatives in the recent past have

been the use of the “green corridor” (organ donation van)

in Rajasthan to transfer milk to needy NICUs from the

collection centers in record time, as well as the establish-

ment of a mobile van equipped with a breast pump and a

refrigerator for collecting donor milk from mothers in the

community in the state of Maharashtra. The Human Milk

Banking Network of India has been established to share

best practices and create awareness among health-care

providers. Media engagement has also increased over

the past year and the issue is well covered across multiple

platforms.

As a next step, as policy and technical leaders work toward

implementing these guidelines to ensure that all infants have

access tohumanmilk (bothMOMandsafedonorhumanmilk),

it will be imperative that the following initiatives are taken

(Table 2).

Effective scale up of human milk banking systems in

India has significant potential. Estimates suggest that

30% to 50% of neonates admitted to the NICU and 10% to

20% of full-term infants are in need of donor human

milk to meet the short- or long-term lack of mother’s

milk. Increasing access to human milk has the potential

to help approximately 5 million infants. When combined

with enhanced breastfeeding methods, the impact could

be 10-fold. (38)

As humanmilk banking systems expand and strengthen,

this will not only have an impact on the immediate

health of neonates but will also have long-term positive

effects. India bears the highest global burden of neo-

natal births and deaths, therefore improvement in neo-

natal health indicators will help India and the world

achieve their goal of reduced neonatal mortality and

morbidity.

ACKNOWLEDGMENTS

Our special gratitude and acknowledgment is extended to

the policy and technical experts in India who provided

insights and guidance, which formed the basis of this

work. We also acknowledge the human milk banks in

India that are dedicated toward increasing access of

human milk to all infants by promoting breastfeeding

and providing safe donor human milk, and saving infant’s

lives.

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