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Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7
Infant Formula
Table of contents
Key points ________________________________________________________ 1
Overview _________________________________________________________ 1
Recommendations for practice _________________________________________ 2
International Code of Marketing of Breast Milk Substitutes ___________________ 2
Definitions ________________________________________________________ 4
Role of health professionals ___________________________________________ 5
Practical assistance _________________________________________________ 5
Operational Directive on Infant Formula Companies and Supplies _____________ 5
General information _________________________________________________ 7
Types of infant formula _______________________________________________ 7
Modified and/or added nutritive substances _______________________________ 9
Specialised infant formula ___________________________________________ 11
Allergy prevention _________________________________________________ 12
Allergy management _______________________________________________ 12
Drinks not suitable for infants (0 – 12 months) ____________________________ 14
Feeding requirements ______________________________________________ 14
Feeding equipment_________________________________________________ 16
Sterilising equipment and methods ____________________________________ 16
Preparing infant formula _____________________________________________ 18
‘Ready to drink’ formulas ____________________________________________ 19
Preparing feeds in advance and warming formula _________________________ 19
Feeding an infant formula ____________________________________________ 20
Transporting formula feeds __________________________________________ 20
Related policies, procedures and guidelines _____________________________ 21
References _______________________________________________________ 21
Professional resources ______________________________________________ 23
Resources for families ______________________________________________ 23
Appendix A: Infant formulas __________________________________________ 24
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7
List of tables
Table 1: Key points__________________________________________________1
Table 2: Allergies: summary of recommended milk feeds____________________13
Table 3: Estimated energy requirements (EER) and fluid requirements_________15
Table 4: Average daily formula requirements for infants and toddlers___________15
Table 5: Sterilisation by boiling_________________________________________16
Table 6: Sterilisation using chemicals____________________________________17
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 1
Section 5: Infant Formula
Aim: Provide targeted, individualised and accurate information on the selection, preparation, use, storage and handling of infant formula, including the health risks of inappropriate preparation and use.
Key points
Table 1: Key points
Given the significant health benefits to both infant and mother, health professionals have a responsibility to promote breastfeeding first, but if infant formula is needed, to educate and support parents about formula feeding.
A mother’s informed decision not to breastfeed should be respected and supported by health professionals and/other members of the multidisciplinary team.
When infants are not breastfed, infant formula is the only suitable and safe alternative to meeting their primary nutritional needs.
Infant formula requires accurate reconstitution and hygienic preparation to ensure its safety, so it is important that health professionals know how to demonstrate the preparation of infant formula and how to feed an infant with a bottle.
Cow’s milk-based formula is suitable for the first 12 months of life unless the infant cannot take cow’s milk-based products for specific medical, cultural or religious reasons, in which case special formulas may be used under medical supervision.1
Overview
The World Health Organization (WHO) states that breastfeeding is an unequalled way of providing ideal food for the healthy growth and development of infants.2 Health professionals have a responsibility to encourage the initiation and maintenance of breastfeeding and avoid any role in the marketing and promotion of infant formula. In addition, educational materials about infant feeding should unequivocally support breastfeeding as the normal and standard way to feed infants.1
If an infant is not breastfed or is partially breastfed, commercial infant formulas are the only acceptable alternative to breast milk for the first 12 months. Infant formula can meet all the infant’s nutritional requirements for the first 6 months.
If infant formula is used, it is the responsibility of health professionals to:
explore the social, physiological and/or medical reasons for formula feeding
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 2
provide accurate and relevant information
ensure best practice is promoted
minimise the risks associated with formula feeding, and
avoid inducing guilt in the mother.1, 3
Recommendations for practice
The following summary of recommendations is taken from the NHMRC’s Infant Feeding Guidelines 2012.1
Standard cow’s milk-based formula labelled ‘suitable from birth’ is safe and suitable for term infants from birth to 12 months of age, where breastfeeding is contraindicated, or where the mother chooses not to breastfeed.
Follow-on formulas are not necessary for healthy infants aged 6-12 months and are designed as a dietary supplement for 6-12 month old infants not meeting their dietary needs through breast milk and/or family foods.
Whole cow’s milk is not recommended as a main milk drink for children under 12 months.
By 12 months of age, infants should be encouraged to eat a wide variety of family foods to ensure nutrition requirements are met. Toddler milks are designed as a dietary supplement for children 1-3 years who are not meeting their nutritional needs through family foods and/or breast milk. Special complementary foods or milks for toddlers are not required for healthy children.1
Specialised formulas are designed for infants with specific medical needs and should only be used for clinically diagnosed conditions.
Changing the type of formula used because of minor rashes, irritability and/or infant or parent distress is usually of no benefit. Changing formula can also create confusion with formula preparation.1
Formula can be selected on the basis of medical and nutritional needs of the infant. Health professionals can advise parents to select infant formula according to the infant’s individual health needs, the cost comparison between brands, and availability for the family.1
For formula-fed infants, cooled boiled tap water may be used if additional fluids are needed. From around 6 months, small amounts of cooled boiled water can supplement breast milk or infant formula. Consuming any other drinks in the first 12 months may interfere with an infant’s adequate intake of breast milk or infant formula.1
After 12 months, water and whole cow’s milk should be the main drinks offered. Where available, clean and safe tap water should be offered, especially if it contains fluoride.
For children 2 years and older, reduced fat milk is recommended.4
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 3
International Code of Marketing of Breast Milk Substitutes
To provide safe and adequate nutrition for all infants, including formula-fed infants, the International Code of Marketing of Breast Milk Substitutes (WHO Code) was developed. The WHO Code encourages informed infant feeding choice and appropriate marketing of breast milk substitutes, feeding bottles and teats.
In support of the WHO Code, the Australian government developed the Marketing in Australia of Infant Formula: Manufacturers and Importers Agreement (MAIF Agreement).5
The MAIF Agreement aims to ensure safe and adequate nutrition for infants by protecting the promotion of breastfeeding and by ensuring the proper use of infant formula on the basis of adequate information and through appropriate marketing and distribution.1
Interpretation and implementation of the WHO Code in Australia1
Section 8.2 of the Infant Feeding Guidelines: Information for Health Workers (IFG) is devoted to the implementation of the WHO Code for health workers in Australia. The following is a summary of the main points covered by the MAIF Agreement and the IFG 1:
The restrictions in the WHO Code apply to infant formula and other products marketed or represented as breast milk substitutes and to feeding bottles and teats. Responsibilities are outlined for companies that manufacture, market or distribute these products, as well as for health professionals and the health care system.
Educational materials produced by companies for parents must be unbiased and consistent; include all the facts, describe all the hazards, and avoid reference to a specific product. Distribution of materials must be only through the health care system, not through retail outlets.
Infant formula companies are not permitted to promote their products to the general public, either directly or through retail outlets. Companies may not give samples or gifts to parents. Health professionals may not give samples to parents.
Health professionals should consider the message about infant feeding that their actions and their health care facility gives to mothers. There must be no display or distribution of products or of company materials that refer to a product or encourage artificial feeding.
Marketing personnel - even if they are health professionals - must have no contact with parents and not perform any educational or health care functions.
Companies may provide scientific and factual information about their products directly to health professionals through meetings or materials.
Companies may not offer, and health professionals may not accept, gifts or other inducements that might influence a health professional’s product
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 4
recommendations to parents or their health care facility. Study grants may be accepted in some circumstances, but they must be disclosed.
All products within the scope of the WHO Code must conform to standards for quality, composition and labelling.
Independently of measures taken to implement the WHO Code, companies and health professionals must take steps to conform to the principles and aim of the WHO Code and to monitor their own practices.
In Australia, concerns about or breaches of the MAIF Agreement must be reported to the Department of Health in Canberra. Complaints should be submitted to the Department of Health on the Complaint Form. The link below provides more information on the complaint process. Information for Lodging Complaints.
MDP 802, GPO Box 9848, Canberra ACT 2601, Phone: (02) 6289 7358
Definitions
To assist communication related to infant formula, health professionals are encouraged to use the definitions listed in Clause 3 of the MAIF Agreement.5
Breast milk substitute Any food marketed or otherwise represented as a partial or total replacement for breast milk, whether or not suitable for that purpose.
Health care system Governmental, non-governmental or private institutions engaged directly or indirectly, in health care for mothers, infants and pregnant women and nurseries or child-care institutions. It also includes health professionals in private practice. For the purposes of the MAIF Agreement, the health care system does not include pharmacies or other retail outlets.
Health professional A professional or other appropriately training person working in a component of the health care system, including pharmacists and voluntary workers.
Infant formula Any food described sold as an alternative for human milk for the feeding of infants up to the age of twelve months and formulated in accordance with Australian Food Standard R7 – Infant Formula.
Label Any tag, brand, mark, pictorial or other descriptive matter written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of infant formulas.
Marketing Includes the promotion, distribution, selling, advertising, public relations and information services related to infant formulas.
Samples Single or small quantities of an infant formula provided without cost. (WHO Code Article 3).
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 5
Role of health professionals
Pregnant women should be informed of feeding options before they have their baby, preferably in antenatal education. The decision to breastfeed or not, should be an informed one. To assist in the decision making process, all pregnant women and their partners should have the opportunity to discuss feeding methods with their midwife or doctor.1
Reading materials on infant feeding should be supplied, as well as contact details for community groups that offer information and support for women who intend to breastfeed1, e.g. WA Health’s “Welcome to your New Baby” and other publications; and Australian Breastfeeding Association publications.
As part of the antenatal education provided, the benefits of breastfeeding should be outlined, as well as the risks of not breastfeeding, without inducing guilt. Some of these risks include:
wrong concentration of formula made up in the home accidentally
immature immune system - making the infant more prone to illness
manufacturing errors in formula and equipment production
poor hygiene when preparing formula increasing the risk of bacterial infection.1
Hospital consent forms
A woman whose baby requires supplementary feeds in hospital, or who chooses to complementary feed, must be asked to sign a consent form. The consent form must outline the advantages of breastfeeding, the risks associated with not breastfeeding, and the rationale for the infant formula supplementation, e.g. allergy risk established. The implications of complementary feeding for establishing and maintaining successful breastfeeding should also be discussed.1 Practice in relation to this varies at different hospitals within WA.
Practical assistance
The WHO Code states that feeding with infant formula should be demonstrated only by health professionals, and only to those mothers or family members who need to use formula.6 Instructions on infant formula preparation and feeding are considered as targeted interventions. It should only be given individually (not in a group setting), and in an area away from breastfeeding mothers.
While breastfeeding is recommended for all infants, if infant formula is used, it is essential that health professionals demonstrate the correct methods of preparing formula. Information provided should include instructions for preparing infant formula and an explanation of the health hazards of inappropriate preparation and use.6
Parent practice and understanding should be regularly checked.
Operational Directive on Infant Formula Companies and Supplies
The WA Health’s Operational Directive on “Infant Formula Companies and Supplies” (OD0204/09)7 outlines WA Health staff responsibilities regarding the acceptance,
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 6
marketing and distribution of infant formula in hospitals and community health services statewide are outlined in the Department of Health WA’s Operational Directive on Infant Formula Companies and Supplies. The Operational Directive aims to ensure safe and adequate nutrition for infants by protecting the promotion of breastfeeding, ensuring the proper use of infant formula on the basis of adequate information, and through appropriate marketing and distribution.
Pharmaceutical company representatives
All pharmaceutical representatives, including those supplying infant formula, wishing to visit hospital staff, must first contact the hospital’s chief dietitian or chief pharmacist. All WA Health staff are encouraged to adhere to their relevant Nutrition and Dietetics department or Pharmacy department guidelines.
Infant formula company representatives wishing to demonstrate products at community health facilities and distribute information to staff must first contact the Nutrition policy officer, Child & Adolescent Community Health Policy (Statewide).
Infant formula samples
WA Health staff may not give branded samples to the general public. Supply of any infant formula and branded written materials to the general public by a health professional or health facility may be reasonably interpreted as endorsement of the product. Note: Refer to local hospital guidelines regarding the provision of infant formula within the context of appropriate clinical care.
Information and education materials from infant formula companies
Infant formula companies may only provide scientific and factual information about their products to staff through meetings or materials, as approved by the Area Health Service Nutrition and Dietetics department or Pharmacy department or Policy unit. Only new or updated informational and educational materials (written, audio or visual) that comply with the MAIF Agreement, clause 4(a) and 7(a) will be permitted for distribution. All products within the scope of the WHO Code must also conform to standards for quality, composition and labelling.
Where appropriate, information from infant formula companies will be incorporated into the resource: ‘Child and Antenatal Nutrition: a guide for community and child health professionals’.
WA Health professionals should also consider the message about infant feeding that their actions and their health service gives to parents. There must be no display or distribution of products or company materials that refer to a product or encourage artificial feeding. Refer to Operational Directive OD 0510/14 “Display of External Advertising Materials in WA Health Facilities”.8
Companies may not offer, and WA Health professionals may not accept, gifts or other inducements that might influence a health professional’s product recommendations to parents or health service. Refer to Western Australian Public Sector Standards regarding the receipt of gifts and sponsorships. Research and study grants must be disclosed and comply with the Royal Australasian College of
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 7
Physicians (RACP) Guidelines for the Funding of Paediatric Research by Formula Companies.
General information
The constituents of human milk are used as a reference in developing infant formula. Although research into the development of formulas is continuing, it is unlikely that these products could ever duplicate the variety of nutrient and active factors present in human milk.1 These include:
The composition of human milk is continually changing within a feed, during a 24-hour period and with the age of the infant.
Human milk contains antibodies (secretory IgA, IgG and IgM), live cells (macrophages, lymphocytes, neutrophils and epithelial cells) and other bioactive substances.
Human milk contains human protein.1
All infant formulas sold in Australia must meet nutritional and safety standards set out in Standard 2.9.1 Infant Formula Products of the Australian New Zealand Food Standards Code.3 The Standards also allow for voluntary addition of permitted forms of nutritive substance, e.g. nucleotides, lutein and other ingredients such as lactic acid cultures, etc. The Standard is available from Food Standard 2.9.1 - Infant Formula Products.3
Infant formulas are available in ready-to-use or powder form. Food Standards Australia New Zealand (FSANZ) regulate standards for the quality, composition and labelling of infant formulas sold in Australia.
Types of infant formula
Formula can be selected on the basis of infant needs. Although there are many cows’ milk-based formulas available, there is little evidence that any one is superior for normal term infants.1 Likewise, the use of a formula by a hospital does not mean that formula is preferable to any other. All brands are regulated under the Australian New Zealand Food Standards Code for Infant Formula Products (Standard 2.9.1) and must be nutritionally complete.1 See Appendix A for infant formula products.
Cow’s milk-based formula is suitable for most term infants and recommended over formula made from soybeans or goat’s milk, modified lactose formula, or specialised formulas, unless specific need is indicated.1
Specialised formulas are designed for infants with specific nutritional needs and should only be used, with medical and/or health professional supervision, for clinically diagnosed conditions, and are outlined in detail later in this document.1
Standard ‘starter’ formulas are labelled ‘suitable from birth’ and are suitable for infants from birth to 12 months.
Follow-on formulas are suitable for over 6 months only. Although follow-on formulas are a better alternative to cow’s milk in the second six months of life when infants are transitioning to solid family foods, they are not considered necessary and no studies have shown advantages over using standard ‘starter’ formula. Follow-on formula
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 8
generally have higher protein, iron and mineral content intended to address possible concerns such as risk of iron deficiency during the transition to solid foods. Encouraging the introduction of a wide variety of appropriate family foods during this transition period to meet nutrition requirements is the first choice.1
Toddler milks are not considered infant formula but rather a formulated supplementary food or dietary supplement for children 1-3 years who are not meeting their nutritional needs through family foods and/or breast milk. They are cow’s milk-based with additional nutritive substances such as probiotics, prebiotics, iron, zinc and iodine. They are only suitable from 12 months as they are not nutritionally complete, and are not required for healthy children.1
Infant formula manufacturers continually develop and produce new products to closer mimic breast milk. More evidence is required to indicate clear long-term benefits for the use of additional nutritive substances voluntarily added to infant formula. Therefore, health professionals can advise parents to select infant formula according to the infant’s individual health needs, the cost comparison between brands, and local availability for the family.
Cow’s milk-based formula
Traditionally, infant formulas have been based on cow’s milk, with varying proportions of casein and whey proteins. The process used to manufacture infant formula results in a modification in the structure of the cow’s milk proteins.
Cow’s milk-based formulas are suitable for most healthy term infants. They are ‘nutritionally complete’, meaning they meet the daily nutrient requirements of infants to 6 months of age.
Soy-based formula
Soy is a source of protein that is inferior to cow’s milk, with a lower digestibility, and bioavailability, as well as a lower methionine content. For soy protein infant formula, only protein isolates can be used, and minimum protein content required in the current European Union legislation is higher than that of cow’s milk protein infant formula (2.25 g/100 kcal vs. 1.8 g/100 kcal). Soy protein formula can be used for feeding term infants, but it has no nutritional advantage over cow’s milk protein formula. It contains high concentrations of phytate, aluminum, and phytoestrogens (isoflavones), which may have untoward effects. According to the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), there is no data to support the use of soy protein formulae in preterm infants.9
Indications for soy protein formula include:
severe persistent lactose intolerance
galactosemia,
ethical considerations (e.g., vegan concepts).9
Soy protein formula has no role in the prevention of allergic diseases10,11 and should not be used in infants with food allergy during the first 6 months of life.11 If soy protein formula are considered for therapeutic use in food allergy after the age of 6
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 9
months because of their lower cost and better acceptance, tolerance to soy protein should first be established by clinical challenge.12 There is no evidence supporting the use of soy protein formula for:
prevention or management of infantile colic or regurgitation
prolonged crying.9
Goat’s milk-based formula
Compared to cow’s milk formulas, there have been fewer studies evaluating the safety and efficacy of goat’s milk formulas. Goat’s milk is not considered to have any role in preventing or treating allergic disease. Many infants who are allergic to cow’s milk are also allergic to goat’s milk and soy drinks. The use of goat’s milk formula is not recommended.1
Modified and/or added nutritive substances
Compared with unmodified cow’s milk and historical efforts to manufacture infant feeds, all modern infant formulas contain reduced protein and electrolyte levels, and have added iron, vitamins (including A, B group, C, D, E and K) and other nutrients. Although research into the components of formulas is continuing, it is unlikely that these products could ever duplicate the variety of nutrient and activity factors present in human milk or the changing nature of breast milk during the course of a feed.1
In recent years, Food Standards Australia and New Zealand has allowed voluntary addition and modification of permitted nutritive substances, which are naturally found in breast milk, and which may be of benefit to infant health. Several of these are discussed below. See Appendix A for a summary of infant formula products.
Long Chain Polyunsaturated Fatty Acids (LCPUFAs) 3
LCPUFAs are nutritive substances added to infant formula, which is usually then labelled as ‘Gold’. LCPUFAs play an important role in the development of an infant’s visual and central nervous system. Breast milk contains pre-formed LCPUFAs, namely DHA (docosahexaenoic acid) and AA (arachidonic acid), and their precursors, ALA (alpha-linolenic)/omega-3, and LA (linoleic acid)/omega-6, meeting all of the essential fatty acid requirements of the growing infant. Rapid brain accumulation of DHA and AA is dependent prenatally on placental transfer and postnatally on dietary sources and limited endogenous synthesis.
Research evidence suggests that formula-fed infants require dietary pre-formed DHA and AA to match the tissue accretion rates of infants receiving DHA and AA from breast milk.13
It has been suggested that low levels of LCPUFAs found in formula milk may contribute to lower cognition and vision skills in term infants. Recent systematic reviews from the Cochrane Library concluded that feeding term infants with milk formula enriched with LCPUFA had no proven benefit regarding vision, cognition or physical growth.14
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 10
Alpha-lactalbumin and reduced total protein
The protein in infant formula is either casein or whey dominated. The amino acid content differs from breast milk and a higher protein level is required to meet minimum amounts of specified amino acids, especially tryptophan.1
Some formulas have reduced total protein and added alpha-lactalbumin, a whey protein, making the formula more comparable to the ratio of whey to casein in breast milk. Alpha-lactalbumin is claimed to be rich in the essential amino acids tryptophan and cysteine. There is evidence that tryptophan helps regulate sleep, appetite and mood, while cysteine has a role in brain development.15
Lower protein intake in infancy is thought to diminish the later risk of overweight and obesity as well as chronic disease in adulthood. Recent research studies in Europe have led to the quality of protein in many brands of infant formula being improved, thereby enabling the overall protein levels to be reduced.1,16,17 The impact of lower protein formulas on growth continues to be researched and some recent evidence suggests that lower protein levels (1.28 g/100mL) were safe and supported growth.18
New evidence suggests that the preferred levels of protein in formula to promote optimal growth rates similar to breastfed infants are those that are similar to the levels in human milk, subject to a minimum content of specific amino acids.1, 19 Human breast milk contains 1 -1.1 grams of protein/mL compared to cow’s milk with 3.3 g/100mL.1 The protein content in infant formulas now available Australia is in the range of 1.3 – 2.0 g/100 mL, with goat’s milk formula at the high end of this range.1
Probiotics and Prebiotics
Probiotics are dietary supplements containing potentially beneficial bacteria and yeast. The rationale for the addition of probiotics to infant formula is to simulate breast milk, which favours the growth of bifidobacteria and represses the growth of unfavourable gastrointestinal bacteria. These effects are both likely to contribute to the protection that breast milk provides against intestinal infection. Probiotics are also proposed as a practical approach to the management of gastrointestinal and systemic conditions in infants, including antibiotic-associated diarrhoea, viral gastroenteritis and allergy.
Prebiotics are non-digestible components of foods, usually a fibre, that are used by beneficial gastrointestinal bacteria as food, boosting their growth in the large bowel. Breast milk contains galacto-oligosaccharides (GOS) which stimulate the growth of bifidobacteria in the infant gastrointestinal tract. The Food Standards Code currently permits the addition of prebiotics, e.g. inulin, resistant maltodextrin, to standard infant formula and toddler milk.
The Infant Feeding Guidelines released in 2012 state that the evidence to support the effect of probiotics and prebiotics in infant formula on prevention of atopic disease varies. It states that two Cochrane reviews and a review by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition concluded there was insufficient evidence to recommend their use.1
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 11
Specialised infant formula
Anti-reflux (AR) formulas
Gastro-oesophageal reflux (GOR/GER) is a descriptive term for the reflux of stomach contents into the oesophagus. In mild form, this is a normal physiological process. It occurs more frequently in neonates than in older infants and children, and is found with higher rates in infants born prematurely. It is most commonly due to transient relaxation of the lower oesophageal sphincter.20
Thickening the milk feed is a simple strategy and commonly used as first line treatment for gastro-oesophageal reflux. However, there is no current evidence from randomised trials to show that adding feed thickeners to milk for newborn infants is effective in treating gastro-oesophageal reflux.21 For the anti-reflux formulas, the NASPGHAN & ESPAGHAN clinical practice guidelines on reflux management (2009) state that AR formulas may decrease visible regurgitation but do not result in a measurable decrease in reflux episodes.21
Other treatment strategies include positioning babies on their stomach or side (but not to sleep), and using medications that either suppress acid in the stomach or cause food to move more rapidly through the stomach.20,21 WA Department of Health’s operational directive (OD 0139/08) WA Health Safe Infant Sleeping Policy and Framework outlines safe infant sleeping practice for health professionals.
Prematurity (Pre-term infants) formulas
Pre-term infants have special nutritional needs related to their birth gestation, birth weight, chronological age and medical history.
Although breast milk is best for preterm infants, the protein and energy content may be insufficient to meet the high levels recommended for these infants. In the hospital setting, multi-component breast milk fortifiers may be added to expressed breast milk to promote adequate growth. Formula-fed, preterm infants are fed preterm infant formula. Breast milk fortifiers and preterm formula are routinely ceased as preterm infants approach term corrected-age.
A small number of infants demonstrate persistent, suboptimal weight gain during their hospital stay and after discharge may need additional nutrients to those provided by breast feeding or term infant formula. These infants may need to continue fortified breast milk feeds or, if formula-fed, an enriched formula for a brief period of time beyond discharge.22 The decision to continue fortified expressed breast milk feeds or to use an enriched formula should be made by the paediatrician and dietitian. The growth of infants receiving fortified or enriched feeds should be closely monitored.
Infants with appropriate weight for chronological age at discharge should be breastfed where possible. If formula fed, these infants can be fed standard infant formula.23 Early nutrition support of preterm infants influences long-term outcomes. Close monitoring of growth post-hospital discharge is recommended to enable the provision of adequate nutrition support.22,23
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 12
Infants with low birth weight may also require increases in protein and energy intake to promote adequate growth. Close monitoring by paediatrician and dietitian is required in these cases.
Lactose-free formulas
These formulas are cow’s milk-based and lactose-free. They are most commonly used for infants with secondary lactose intolerance, i.e. a temporary and common lactose intolerance occurring after gastroenteritis. Following diagnosis, affected infants are usually placed on a lactose-free formula for anything from a few days up to four weeks. The medical practitioner will then advise when to commence the incremental challenge with their usual formula.
Lactose-free formulas are also used for primary lactose intolerance in infants, which is very rare, although may develop later in life especially in people of Asian ethnic origin.24
HA,‘hypoallergenic’ or partially hydrolysed formula
In Australia and New Zealand, partially hydrolysed formulas (usually labeled ‘HA’ or Hypoallergenic) are recommended for allergy prevention for high-risk infants who are unable to breastfeed.25 See Appendix A for specific formula products.
HA formulas are made from 100% partially hydrolysed whey. The protein size is smaller than other standard infant formulas, however larger than therapeutic hypoallergenic formula. There is some evidence that HA formula may reduce the initial onset of some allergic manifestations in non-breastfeeding infants deemed to be at high risk, i.e. children with a history of allergies in their parents or siblings.26
However, HA formulas are not suitable for use in the treatment or management of cow’s milk allergy. Different specialised hypoallergenic infant formulas, i.e. extensively hydrolysed formula (EHF) and free amino acid-based formulas (AAF), will be required in this case. These are available on prescription, in conjunction with health professional support.25
Allergy prevention
The Australasian Society of Clinical Immunology and Allergy (ASCIA)25 recommends exclusive breastfeeding for at least six months for children at high risk of allergic disease, i.e. children born into atopic families, to prevent or delay atopic dermatitis, food allergy and wheezing in early childhood. If breastfeeding is not possible, a partially hydrolysed formula (HA formula) is recommended rather than standard cow’s milk based formula (Refer to Table 2). Soy and other (e.g. Goat’s milk) formulas are not superior to regular formula for reducing food allergy risk. Probiotic supplements (or other microbial agents) and LCPUFA cannot currently be recommended for allergy prevention. 1
Allergy management 24, 26
Formulas of extensively hydrolysed whey (Alfare, Pepti-Junior, Aptamil, Allerpro) and amino acids (Elecare, Neocate) can be suitable for infants with a medically detected or suspected allergy or intolerance to cow, soy or goat milk or infant formula.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 13
Usually an extensively hydrolysed protein formula (EHF) is the first choice and, if this is not tolerated, an amino acid formula (AAF) will be required. In severe cases of allergy/intolerance, the health care specialist may recommend starting with an amino acid formula as the first option (Refer to Table 2). Extensively hydrolysed formula has smaller proteins compared to standard and HA formulas. Amino acid formula has the smallest protein size of all the formulas. In general, the smaller the protein, the less allergenic it is, but it is also more expensive and unpalatable.
To encourage intake of these formulas, parents may try offering it cool rather than warm to decrease the taste. Having a non-breastfeeding person feed the formula to the infant may also help, as the smell of breast milk may be a distraction. Other options are to flavour the formula under the guidance of a dietitian, or mix the formula with the child’s usual milk until the new formula is accepted.
Table 2: Allergies: summary of recommended milk feeds12
First choice Second choice*
*if 1st choice is not tolerated
Third choice**
**if 1st and 2nd choice is not tolerated
Allergy prevention (infant with family history of allergic disease)
0 - 6 months Breast milk HA EHF
6 - 12 months Breast milk CM-based HA
Allergy treatment (infant with diagnosed cow’ s milk allergy)
Anaphylaxis at any
age
Breast milk AAF AAF
0 - 6 months (non-anaphylaxis)
Breast milk EHF AAF
6 - 12 months (non-anaphylaxis) Depends on allergic syndrome but soy not always recommended.
Breast milk Soy infant formula
EHA
EHF
AAF
CM-based – regular, cow’s milk-based formula
HA – partially hydrolysed or hypoallergenic formula
EHA – extensively hydrolysed formula (prescription required)
AA – free amino acid based formula (prescription required)
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 14
Currently there is no evidence to suggest a breastfeeding mother should exclude any particular foods from her diet except where a medical practitioner advises her to do so, which might happen if the infant has been diagnosed with an allergy.26
Drinks not suitable for infants (0 – 12 months)
Cow’s milk
All forms of cow’s milk are unsuitable for infants under 12 months of age, including:
fresh or long-life whole, skim, fat-reduced
powdered milk
diluted cow’s milk with sugar
evaporated milk
sweetened condensed milk.
The composition of cow’s milk is inappropriate for infants as the levels of protein, sodium, potassium, phosphorous and calcium are higher than breast milk and formula, while levels of iron, vitamin C and linoleic acid are lower. The high levels of protein, sodium and potassium can place excessive stress on the young kidneys, while the iron in cow’s milk is poorly absorbed, predisposing infants to iron deficiency. Small amounts of cow’s milk in foods such as yoghurt, cheese and custard that are prepared for the rest of the family as well as addition of cow’s milk to breakfast cereals can, however, be given after about 8 months.1
Goat and sheep’s milk
Goat and sheep’s milk have overall nutrient profiles similar to cow’s milk and are therefore not recommended until 12 months of age. Goat and sheep milks are generally not pasteurised and this creates an additional health risk.1
Soy, rice, oat, almond and other vegetarian beverages
Whether fortified or not, these are inappropriate alternatives to breast milk, infant formula or pasteurised cow’s milk in the first two years of life.1
Feeding requirements
Formula-fed infants should be fed according to need and appetite. The amount of formula and the number of bottles an infant will take in a 24-hour period will vary, even among individuals. The information on formula packages is a guide only and is not necessarily suitable for every infant.
Indicators that an infant is getting enough formula include:
plenty of wet nappies ( 6 or more per day)1
consistent weight gain (not excessive)
a thriving and active infant. 1
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 15
Table 3 provides a guide for the estimated energy and fluid requirements for infants up to two years of age.
Table 3: Estimated energy requirements (EER) and fluid requirements27
Age Total EER Fluid requirements
0-6 months 7-12 months 12-24 months
1800 – 2700 kJ/day 2500 – 3000 kJ/day 3200 – 4400 kJ/day
0.7 L/day * (breast milk or formula) 0.8 L/day** (from breast milk, formula, food, plain water and other beverages, including 0.6 L/day as fluids) 1.0 L/day (including plain water, milk and other drinks)
* This adequate intake (AI) for infants aged 0-6 months is based on the content of breast milk or formula in healthy mothers assuming a breast milk volume of 0.78 L/day and rounding where appropriate (reference body weight is 7kg). Breast milk is 87% water.
** NB: The breast milk intake is assumed to be 600 mL/day. This would supply 0.52 L water/day. An amount of 0.32 L is added for water from complementary foods to give a total of 0.84 L/ day rounded to 0.8 L/day.
As with breastfeeding, bottle-feeding according to need is appropriate. Formula is designed to remain at a constant strength. As an infant grows, the amount of formula should increase, not the strength. Bottle-fed infants up to 6 months require about 150 mL/kg body weight each day to meet their nutrient needs. Some will require more (up to 200 mL/kg), others less. It is important for parents to be aware that there are many individual variations in the amount of formula and the number of bottles consumed in 24 hours. Information on formula packages recommending certain amounts for various ages is a guide only and does not necessarily suit every infant.1 A guide to average daily formula requirements is shown in Table 4.
Table 4: Average daily formula requirements* for infants and toddlers1
Days 1 - 4 30 – 60 mL / kg / and increase over the next few days
Day 5 to 3 months 150 mL / kg / day Some infants (e.g. Premature or low birth weight) may require up to 180–200mL
3 to 6 months 120 mL / kg / day
6 to 12 months 100 mL / kg / day Some may reduce to 90mL and some infants also take solids
* values given are a guide only
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 16
Feeding equipment
Feeding cups
A feeding cup can be used instead of a bottle for feeding infant formula or expressed breast milk. The technique used by an infant to suck on the teat of a bottle differs from that used on the breast, and use of a feeding cup instead of a bottle reduces the risk of nipple confusion.
For infants over the age of 6 months, parents may choose to wean onto a cup rather than a bottle. For infants receiving formula feeds, parents should encourage cessation of bottle use by 12 months of age. Feeding cups used for formula or breast milk up to 12 months should continue to be sterilised.1
Bottles and teats
Bottles made of plastic are preferred over glass bottles for safety reasons. Bottles may come in different shapes but there is no evidence that a particular shape prevents wind or colic. Bottles should be easy to clean.1
Teats can be made from rubber (latex) or silicone. Teats need to be checked and replaced regularly, as they can crack and perish. Old teats can house bacteria, and pieces of the teat may dislodge and can be inhaled or swallowed. There is no advantage in shape variation. Several types may need to be tried until a suitable one is found, to ensure the milk flow is at the right rate for the infant.1
Sterilising equipment and methods
There is greater risk of food borne illness and infection resulting from sub-standard sterilisation techniques. The risk of contamination can be reduced if all infant feeding equipment is boiled or otherwise sterilised.1 WA Department of Health’s operational directive (OD 0369/12) Reprocessing of infant feeding equipment in health care facilities outlines the recommended best practice guidelines for the cleaning and disinfection/sterilisation of infant feeding equipment.28
Sterilisation methods
Boiling Boiling is the preferred option for sterilising bottles and other infant feeding equipment. Boiling gives consistent and reliable results if the steps outlined in Table 5 are taken.1
Table 5: Sterilisation by boiling1
1. Wash bottles, teats, caps and cups (where in use) in hot soapy water with a bottle/ teat brush before sterilisation.
2. Place utensils, including bottles, teats and caps in a large saucepan on the back burner of the stove.
3. Cover utensils with water, making sure to eliminate all air bubbles from the bottle.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 17
4. Bring water to the boil and boil for 5 minutes. Turn off – do not allow it to boil dry.
5. Allow the equipment to cool in the saucepan until it is hand hot and then remove it – be very careful if children are present.
6. Store equipment that is not being used straight away in a clean container in the fridge.
7. Boil all equipment within 24 hours of use.
Sterilising using chemicals
A chemical sterilant is an antibacterial solution that comes in liquid or tablet form. Washing bottles and other feeding equipment with soap or detergent until visibly clean, followed by submersion in 50ppm hypochlorite solution for 30 minutes, completely eliminates bacterial contamination. Chemical sterilisation is not as effective as boiling unless bottles and other utensils are meticulously cleaned. Table 6 outlines the chemical sterilisation.1
Table 6: Sterilisation using chemicals1
Follow the manufacturer’s instructions carefully when making up the solution to ensure the correct dilution.
Discard the solution after 24 hours, thoroughly scrub the container and equipment in warm water with detergent and make up a new solution.
Make sure all equipment is made of plastic or glass: metal corrodes when left in chemical sterilant.
Completely submerge everything, making sure there are no air bubbles, and leave it in the solution for at least the recommended time – equipment can be left in the solution until it is needed.
Allow the equipment to drain, do not rinse off the sterilising liquid or there will be a risk of re-contamination.
Store the sterilising concentrate and solution well out of the reach of children.
Steam sterilisers
Steam sterilisers are automatic units that raise the temperature quickly to a level that kills harmful bacteria. Thoroughly cleaned equipment is placed inside the unit, water is added according to the manufacturer’s instructions, and the unit switched on (it switches itself off when sterilisation is complete). 1
Microwave steam sterilisers
Sterilising units designed for use in a microwave oven are available. The caveats that apply to chemical sterilisation also apply to microwave sterilisation.1
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 18
Preparing infant formula1
Safe bottle feeding depends on a number of factors, including:
a safe water supply
sufficient family income to meet the costs of continued purchase of adequate amounts of formula
effective refrigeration
clean surroundings
satisfactory arrangements for sterilising and storing equipment.
Tap water is preferred for preparing infant formula (consistent with the Australian Dietary Guidelines).4 All tap water used to prepare infant formula should be boiled and cooled according to instructions on the formula package label. Bottled water can be used to prepare formula, if unopened, but it is not necessary.1 Bottled water may be helpful when travelling overseas where there is uncertainty about the water quality. Sparkling mineral water or soda water are not appropriate for use.
Parents without literacy skills or from a non-English speaking background may need extra help to make sure bottle-feeding is done safely.1 Correct infant formula preparation techniques are described below.
1. Always wash hands before preparing formula and ensure that formula is prepared in a clean area.
2. Wash bottles, teats, caps and knives – careful attention to washing is essential – and sterilise by boiling for 5 minutes or using an approved sterilising agent.
3. Boil fresh water and allow it to cool until lukewarm – to cool to a safe temperature, allow the water to sit for at least 30 minutes (in places with clean water supply which meets Australian standards, hot water urns such as hydroboils are safe to use for formula reconstitution, provided the supply of very hot water has not been depleted).
4. Ideally prepare only one bottle of formula at a time, just before feeding.
5. Always read the instructions to check the correct amount of water and powder as shown on the feeding table on the back of the pack – this may vary between different formulas.
6. Add water to the bottle first, then powder.
7. Pour the correct amount of previously boiled (now cooled) water into a sterilised bottle.
8. Always measure the amount of powder using the scoop provided in the can, as scoop sizes vary between different formulas.
9. Fill the measuring scoop with formula powder and level off using the levelling device provided or the back of a sterilised knife – the scoop should be lightly tapped to remove any air bubbles.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 19
10. Take care to add the correct number of scoops to the water in the bottle – do not add half scoops or more scoops than stated in the instructions.
11. Keep the scoop in the can when not in use – do not wash the scoop as this can introduce moisture into the tin if not dried adequately.
12. Place the teat and cap on the bottle and shake it until the powder dissolves.
13. Test the temperature of the milk with a few drops on the inside of your wrist – it should feel just warm, but cool is better than too hot.
14. Feed infant – any formula left at the end of the feed must be discarded.
15. A feed should take no longer than 1 hour – any formula that has been at room temperature for longer than 1 hour should be discarded.
16. Unused formula that has been at room temperature for less than 1 hour may be stored in a refrigerator for up to 24 hours (in a sterile container) – discard any refrigerated feed that has not been used within 24 hours.
17. When a container of formula is finished, throw away the scoop with the container, to ensure that the correct scoop is used next time.1
‘Ready to drink’ formulas
‘Ready to drink’ infant formula products are available in aseptically packed glass bottles for hospital use only or in aseptically packed tetra packs for domestic use. The liquid formula needs to be poured into a sterilised bottle and can be warmed in the bottle if desired, just before feeding. Once opened, ‘Ready to drink’ formats (glass bottle or tetra pack) may be poured into numerous sterilised bottles provided that these bottles are refrigerated below 5°C continuously and used within 24 hours. Any unfinished formula left in the bottle after a feed must be discarded and not kept for use in a later feed.1
Preparing feeds in advance and warming formula
Ideally only one bottle of formula should be prepared at a time. If formula needs to
be prepared in advance (e.g. for a babysitter), it must be refrigerated (at least 5˚C or
below) and used within 24 hours. Alternatively, prepared sterilised bottles of boiled water may be refrigerated and used as required), first warming by standing in a container of warm water and then adding formula. 1
Babies can be fed cold formula, but formula that has been warmed to room temperature tends to flow faster and is generally preferred. The safest way to heat infant formula is to stand it in a container of warm water. 1
Microwaves are not recommended as they don’t heat evenly. When milk is heated in the microwave, the temperature can be easily misjudged and infants can receive burns to the mouth if the milk contains hot spots. Milk should not be left out of the refrigerator to warm to room temperature. 1
The temperature should always be checked by shaking a little milk from the teat onto the inside of the wrist before feeding. The formula should feel warm not hot.1
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 20
Feeding an infant formula
When feeding an infant, the milk should drip easily at a steady rate without pouring out in a stream. To determine the flow rate of a teat, the bottle should be filled with room-temperature milk and held upside down. The milk should drip steadily.
If the bottle has to be shaken vigorously, the teat is too slow. A slow teat may result in the infant falling asleep before taking all the milk he or she needs. A little leakage at the corners of the mouth during feeding is not a concern – this stops as infants get older. If an ideal teat can’t be found, a faster teat is usually preferable to a slower one. 1
Good practice in bottle-feeding involves making feeding a comfortable experience for parent and infant while avoiding risks associated with incorrect bottle-feeding. This includes:
always checking the temperature of the formula before feeding by shaking a little milk from the teat onto the inside of the wrist – it should feel warm, not hot
Hold, cuddle and talk to the infant (if it is not too distracting) while feeding and respond to infant cues; parent–infant contact is extremely important.
Do not leave an infant to feed on their own (i.e. with the bottle propped) – the milk may flow too quickly and cause the infant to splutter or choke
not putting an infant to sleep while drinking from a bottle – as well as the risk of choking, this increases the risk of ear infection and dental caries.1
NB: Regular monitoring of the infant’s progress is important for all infants including those being formula fed. Constipation may occur when formula is introduced. While formula-fed infants tend to pass firmer and fewer stools than breastfed infants, hard, dry stools may indicate incorrect preparation of formula. If diarrhoea occurs, it may be necessary to briefly interrupt formula feeding for rehydration.1
Transporting formula feeds
It is much safer to prepare bottles of infant formula at the destination, rather than transporting bottles of prepared formula.
Harmful bacteria thrive in warm, moist conditions. Ready-made bottles of prepared formula can be a breeding ground for bacteria if the bottles have been sitting in a car or baby bag for several hours, especially on a warm day. Because of the potential for growth of harmful bacteria during transport, feeds should first be cooled to no more than 5°C in a refrigerator and then transported in an insulated container, using ice packs to maintain cool temperature during transport.1
As an alternative, the correct volume of boiled water may be transported safely in a bottle, for addition of formula powder as required, provided that the bottle is adequately sealed to prevent contamination. Single serve formula sachets are available, and recommended under these circumstances; otherwise formula powder should be transported within its original can, and kept cool, according to manufacturer’s instructions.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 21
Related policies, procedures and guidelines
The following can be read in conjunction with this document.
Operational Directive (OD0204/09) - Infant Formula Companies and Supplies
Operational Directive (OP/0984/97) - Advertising in child health centres and community health centres
Operational Directive (OD 0369/12) -Reprocessing of infant feeding equipment in health care facilities
References
1. National Health and Medical Research Council. Infant Feeding Guidelines. Canberra: National Health and Medical Research Council; 2012.
2. World Health Organization. Exclusive breastfeeding statement. 2011.
3. Food Standards Australia New Zealand. Standard 2.9.1 Infant Formula Products. Canberra: FSANZ; 2011.
4. National Health and Medical Research Council. Australian Dietary Guidelines. Canberra: National Health and Medical Research Council; 2012.
5. Advisory Panel on the Marketing in Australia of Infant Formula (APMAIF). Marketing in Australia of Infant Formulas: Manufacturers and Importers Agreement - The MAIF Agreement: Commonwealth Department of Health and Aging; 2003. Available from: http://www.health.gov.au/apmaif
6. World Health Organization. Global Strategy for Infant and Child Feeding Geneva 2003.
7. Western Australia Department of Health. Infant Formula Companies and Supplies (OD0204/09). Perth: Department of Health; 2009.
8. Western Australia Department of Health. Advertising in child health centres and community health centres (OP/0984/97). Perth: Department of Health;1997.
9. Agostoni C, Axelsson I, Goulet O, Koletzko B, et.al. Soy Protein Infant Formulae and Follow-On Formulae: A Commentary by the ESPGHAN Committee on Nutrition ESPGHAN Committee on Nutrition. Journal of Pediatric Gastroenterology and Nutrition. 2006; 42:352-61.
10. Osborn DA, Sinn J. Soy formula for prevention of allergy and food intolerance in infants. Cochrane Database Systematic Reviews 2006;Issue 4:DO I:10.1002/14651858.CD003741.pub4.
11. Canadian Paediatrics Society. Concerns for the use of soy-based formulas in infant nutrition. Paediatric Child Health. 2009;14(2):109–18.
12. Kemp A, Hill DJ, Allen KJ, et al. Guidelines for the use of infant formulas to treat cow's milk protein allergy: an Australian consensus panel opinion. Medical Journal of Australia. 2008;18(1):49-52.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 22
13. Koletzko B, et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. Journal of Perinatal Medicine. 2008;36:5-14.
14. Simmer K, Patole SK, Rao SC. Longchain polyunsaturated fatty acid supplementation in infants born to term (Review). Cochrane Database of Systematic Reviews. 2011 (12).
15. Davis A, Harris B, Lein E, Pramuk K, Trabulsi J. Alpha-lactalbumin-rich infant formula fed to healthy term infants in a multicenter study: plasma essential amino acids and gastrointestinal tolerance. . European Journal of Clinical Nutrition. 2007;62:1-8.
16. Koletzko B, von Kries R, Closa R, Escribano J, Scaglioni S, Giovannini M, et al. Lower protein in infant formula is associated with lower weight up to age 2 years: a randomized clinical trial. American Journal of Clinical Nutrition. 2009;89(6):1836-45.
17. Michaelsen K, Larnkjaer A, Molgaard C. Amount and quality of dietary proteins during the first two years of life in relation to NCD risk in adulthood. Nutr Metabolic Cardiovascular Disease. 2012;22(10):781-6.
18. Trabulsi J, Capeding R, Lebumfacil J, Feng P, McSweeney S, Harris B, et al. Effect of an alpha-lactalbumin-enriched infant formula with lower protein on growth. European Journal of Clinical Nutrition. 2011;65:167-74.
19. Escribano E, Luque A, Ferre N, Mendez-Riera G, Koletzko B, Grote V, et al. Effect of protein intake and weight gain velocity on body fat mass at 6 months of age: The EU Childhood Obesity Programme. International Journal of Obesity. 2012;36(4):548-53.
20. Schurr P and Findlater CK. Neonatal Mythbusters: evaluating the evidence for and against pharmacologic and nonpharmacologic management of gastroesophageal reflux. Neonatal Network. 2012;31 (4):229-241.
21. European Society for Pediatric Gastroenterology, Hepatology and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN. Journal of Pediatric Gastroenterology and Nutrition. 2009;49:498-547.
22. Aimone A, Rovet J, Ward W, Jefferies A, Campbell D, Asztalos E, et al.
Growth and body composition of human milk-fed premature infants provided with extra energy and nutrients early after hospital discharge: 1 year follow-up. Journal of Pediatric Gastroenterology and Nutrition. 2009;49:1-11.
23. Aggett P, Agostini C, Axelsson I, DeCurtis M, Goulet O, Herald O, et al. Medical position paper on feeding preterm infants after hospital discharge: a commentary by the ESPGHAN Committee on Nutrition. Journal of Pediatric Gastroenterology and Nutrition. 2006;42:596-603.
Child and Antenatal Nutrition Manual
Infant Formula
Date Issued: 1997 Infant Formula
Date Reviewed: April 2014
Next Review: April 2017
NSQHS Standards: 1.7 23
24. Fisher R. Formulas and milks for infants and children. Medicine Today. 2007;8(10):39-48.
25. Australian Society of Clinical Immunology and Allergy (ASCIA). Infant Feeding Advice. ASCIA; 2010.
26. Greer FR, Sicherer SH, Burks AW. Effects of early nutritional interventions on the development of atopic disease in infants and children: the role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas. Pediatrics. 2008;121(1):183-91.
27. National Health and Medical Research Council. Nutrient reference values for Australia and New Zealand including recommended dietary intakes: executive Summary [online] 2006. Available from: http://www.nhmrc.gov.au/guidelines/publications/n35-n36-n37
28. Western Australia Department of Health. Reprocessing of infant feeding equipment in health care facilities (OD 0369/12). Perth: Department of Health 2012.
Professional resources
Infant Feeding Guidelines – Information for health workers. National Health and Medical Research Council (2012). Available from:
http://www.nhmrc.gov.au/guidelines/publications/n56
King Edward Memorial Hospital - Clinical Guidelines Section B: Obstetric and Midwifery Care, Section 8 - Newborn Feeding, January 2012. Available from: http://www.kemh.health.wa.gov.au/development/manuals/O&G_guidelines/sectionb/index.htm#8
Resources for families
KEMH pamphlet ‘Formula feeding’. Available from: http://www.kemh.health.wa.gov.au/brochures/consumers/wnhs0277.pdf
Raising Children’s Network. Preparing bottles and making formula. Available from: http://raisingchildren.net.au/articles/pip_formula_preparation.html
24
Appendix A: Infant formulas (as of 01/09/2014) SUITABLE FROM BIRTH All brands are nutritionally complete and meet Australian New Zealand Food Standards Code for Infant Formula Products (Standard 2.9.1) Brand Manufacturer LCPUFA Nucleotides Probiotics Prebiotics AR HA Reduced protein,
added Alpha - lactalbumin
Lactose Free
Comments
STANDARD FORMULA – Cow’s milk based
Heinz Nurture Gold Starter
Heinz Whey dominant, added alpha-lactalbumin
Heinz Nurture Starter Heinz Whey dominant
Karicare+ Infant Formula from birth
Nutricia Powder NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Aptamil® Gold+ Infant Formula from birth
Nutricia Powder and ready-to-feed form NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Nan Comfort 1 Nestle Whey-dominant Probiotic Lactobacillus reuteri
Nan Pro 1 Gold Nestle Powder and ready-to-feed form Whey-dominant, Probiotic Bifidus BL (powder only)
Nan HA 1 Gold Nestle Powder and ready-to-feed form Probiotic Bifidus BL (powder only)
Novalac Stage 1 Gold Bayer
S-26 Gold Newborn Aspen Nutritionals
Powder and ready-to-feed form, reduced beta-lactoglobulin, contains lutein
S-26 Gold Comfort Aspen Nutritionals
Fat blend enriched with Sn2 palmitate, carbohydrate blend with 54% lactose, 100% whey protein partially hydrolysed, and contains lutein
S-26 Original Newborn Aspen Nutritionals
Whey-dominant
SMA Aspen Nutritionals
Casein-dominant
SUITABLE FROM 6 MONTHS All brands are nutritionally complete and meet Australian New Zealand Food Standards Code for Infant Formula Products (Standard 2.9.1)
25
Brand Manufacturer LCPUFA Nucleotides Probiotics Prebiotics AR HA Alpha - lactalbumin
Lactose Free
Comments
FOLLOW-ON FORMULA
Heinz Nurture Follow-on Heinz Casein dominant
Heinz Nurture Gold Follow-on
Heinz Casein dominant
Karicare+ Follow-On Formula
Nutricia NOT suitable for confirmed CMA galactosaemia, lactose intolerance. Not suitable before 6 months of age.
Aptamil® Gold+ Follow-On Formula
Nutricia NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Nan Comfort 2 Nestle Probiotic Lactobacillus reuteri
Nan Pro 2 Gold Nestle Powder and ready-to-feed form Probiotic Bifidus BL(powder only)
Nan HA 2 Gold Nestle Probiotic Bifidus BL(powder only) Follow-on HA formula for older infants
Novalac Stage 2 Gold Bayer
S-26 Original Progress Aspen Nutritionals
S-26 Gold Progress Aspen Nutritionals
Powder and ready-to-feed form, contains lutein
* Note: Some infant formulas sold through specific pharmacies are not listed. Key: LCPUFA = Long Chain Polyunsaturated Fatty Acids, specifically DHA and AA, AR = Anti-Reflux, HA = Hypo-allergenic, CMA = Cow’s Milk Allergy
26
SPECIALISED INFANT FORMULAS
All brands are nutritionally complete and meet Australian New Zealand Food Standards Code for Infant Formula Products (Standard 2.9.1) Brand Manufacturer LCPUFA Nucleotides Probiotics Prebiotics AR HA Alpha -
lactalbumin Lactose Free
Comments
SPECIALISED FORMULAS – Use only with medical advice and/or supervision
Aptamil® Gold De-Lact from birth (0-12 months)
Nutricia NOT suitable for confirmed CMA
Aptamil® AR from
birth (0-12 months)
Nutricia Suitable for healthy bottle fed infants from birth with recurrent or problematic regurgitation when breast milk is unavailable, as a partial or complete breast milk substitute. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Karicare+ Soy
Formula (All Ages)
Nutricia Suitable for vegetarians and those with lactose intolerance. For babies older than 6 months with uncomplicated cows' milk protein allergy. NOT suitable for confirmed soy milk protein allergy.
Karicare+ Goat Infant Formula (0-6 months)
Nutricia NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Karicare+ Goat
Follow On Formula
Nutricia NOT suitable for confirmed CMA, galactosaemia, lactose intolerance. Not suitable before 6 months of age.
Aptamil® Gold+ HA Infant Formula from birth
Nutricia Suitable for infants at risk of allergy as identified by their first degree family history, as a partial or complete breast milk substitute. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance.
Aptamil® Gold+
AllerPro™ Infant
Formula (0-6
months)
Nutricia Suitable for infants from birth to 6 months at
high risk of allergy or with confirmed CMA
and/or soy protein allergy as a partial or
complete breast milk substitute. NOT
suitable for allergy to extensively hydrolysed
cows' milk formula, severe (anaphylactic)
CMA, galactosemia, malabsorption and
primary lactose intolerance.
27
Brand Manufacturer LCPUFA Nucleotides Probiotics Prebiotics AR HA Alpha - lactalbumin
Lactose Free
Comments
Aptamil® Gold+
AllerPro™ Follow-
on Formula
Nutricia Suitable for infants from six months, who are
at high risk of allergy or with confirmed mild
to moderate CMA and/or soy protein allergy,
as a partial or complete breast milk
substitute, as part of a mixed diet
NOT suitable for allergy to extensively
hydrolysed cows' milk formula, severe
(anaphylactic) CMA, galactosemia,
malabsorption and primary lactose
intolerance.
S-26 Lactose Free Aspen
Nutritionals
Listed on the Pharmaceutical Benefits Scheme (PBS)
S-26 Gold Lactose
Free
Aspen
Nutritionals
Contains Lutein
S-26 Gold Soy Aspen
Nutritionals
Contains Lutein
S-26 Gold AR Aspen
Nutritionals
Contains Lutein
S-26 Gold Premgro Aspen
Nutritionals
Post-hospital discharge formula for preterm formula fed infants
Nan AR Nestle Partially hydrolysed 100% whey, Probiotic L. reuteri
Nan L.I. Gold Nestle Lactose free, whey-dominant
Novalac Colic Bayer Reduced lactose formula
Novalac Constipation
Bayer Whey-dominant
Novalac Diarrhoea Bayer For temporary use only (5 days max.)
28
SPECIALISED FORMULAS – medically prescribed for the management of confirmed allergies and intolerances, including cow’s milk protein allergies
Brand Manufacturer LCPUFA Nucleotides Probiotics Prebiotics AR HA Alpha - lactalbumin
Lactose Free
Comments
Alfare` Nestle Extensively hydrolysed formula
Aptamil Gold
Peptijunior
Nutricia Extensively hydrolysed formula, contains
MCT
Aptamil Gold plus
AllerPro
Nutricia Extensively hydrolysed formula; contains
lactose
Neocate Gold Nutricia Amino acid-based formula, contains
MCT
Neocate LCP Nutricia Amino acid-based formula
Neocate Advance/
Neocate Advance
Vanilla
Nutricia Amino acid-based formula.
Used for children over 1 year old.
EleCare
Unflavoured
Abbott Amino acid-based formula. Contains
MCT.
Elecare LCP Abbott Amino acid based formula, contains
MCT.
Elecare Vanilla Abbott Amino Acid based formula, used for
children over 1 year of age.
* Note: Some infant formulas sold through specific pharmacies are not listed. Key: LCPUFA = Long Chain Polyunsaturated Fatty Acids, specifically DHA and AA; AR = Anti-Reflux; HA = Hypo-allergenic; CMA = Cows Milk Allergy; MCT=Medium Chain Triglyceride
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TODDLER MILK SUPPLEMENTS (SUITABLE FROM 12 MONTHS) Toddler milks are not considered infant formula but rather a formulated supplementary food/dietary supplement for children 1-3 years who are not meeting their nutritional needs through family foods and/or breast milk. They are not designed as the sole source of nutrition as they are not nutritionally complete. Toddler milks are cow’s milk-based with additional nutritive substances such as probiotics, prebiotics, iron, zinc and iodine. As with other milk drinks, limit to no more than 600mL per day so as not displace other foods.
Brand Manufacturer LCPUFA Nucleotides Probiotics
Prebiotics AR HA Alpha - lactalbumin
Lactose Free
Comments
Heinz Nurture Toddler Heinz Added iron, zinc, iodine.
Heinz Nurture Gold Toddler Heinz Added iron, zinc, iodine.
Karicare+ Toddler 3 Growing Up Milk (From 1 Year)
Nutricia Sucrose free. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance, or before 12 months of age.
Karicare+ Toddler 4 Growing Up Milk (From 2 Years)
Nutricia Sucrose free. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance, or before 12 months of age.
Aptamil® Gold+ Toddler Nutritional Supplement from 1 year
Nutricia Sucrose free. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance or before 12 months of age.
Aptamil® Gold+ Junior Nutritional Supplement from 2 years
Nutricia Sucrose free. NOT suitable for confirmed CMA, galactosaemia, lactose intolerance or before 12 months of age.
Nan Pro 3 Nestle Reduced protein, modified MUFA:PUFA content, sucrose free, added vitamin B1, B2, C, D, E, calcium iron and zinc.
Nan HA 3 Nestle Reduced protein, modified MUFA:PUFA content, sucrose free, added vitamin B1, B2, C, D, E, calcium iron and zinc.
Nan HA 4 Nestle Reduced protein and fat, modified MUFA:PUFA content, sucrose free, added vitamin B1, B2, C, D, E, calcium iron and zinc.
S-26 Gold Toddler Aspen Nutritionals
Powder and ready to feed form. Added iron, zinc, iodine, calcium, vitamin. Contains lutein. Sucrose-free.