Infant Feeding: Human Milk and Formula Joan C Zerzan MS RD CD

Infant Feeding: Historical Perspective Human Milk Human Milk

Substitutes Science, Medicine

and Industry

Feeding the Infant Considerations

Infant (needs, tolerance, acceptance, safety)

Family preferences Cost and availability Prevention, health,

development, and programming

Feeding the Infant Choices:

Human Milk Standard Infant Formula

(Cow, Soy) Hypoallergenic

(hydrolysates vs. amino acid based

Other specialty formulas Preterm Post discharge formulas

for preterm infants

Human Milk

“No two hemispheres of any learned professor’s brain are equal to two healthy mammary glands in the production of a satisfactory food for infants”

- Oliver Wendell Holmes

Human Milk Complements infant Immaturity Promotes maturation

Epithelial growth factors and hormones

Digestive enzymes - lipases and amylase

Characteristics and Advantages of Human Milk Low renal solute load Immunologic, growth and trophic factors

Decrease illness, infection, allergy Improved digestion and absorption Nutrient Composition: CHO, Protein,

Fatty Acid, etc Cost Other

Human Milk Colostrum

Higher concentration of protein and antibodies

Transitions around days 3-5 Mature by day 10

Human Milk Nutrient composition of human milk

is remarkable for its variability, as the content of some of the nutrients change during lactation, throughout the day, or differ among women, while the content of some nutrients remain relatively constant throughout lactation.

Role of Human Milk Components in GI Development: Current Knowledge and Future Needs: Donovan J Pediatr 2006:149:S49-S61

“ existing clinical and epidemiological studies support a developmental advantage for breastfeeding. However, our understanding of the mechanisms by which HM components exert their actions within the human infant are limited by the large number of bioactive compounds in milk and the complexity of the potential interactions among the components and with the developing intestine”

Human Milk Compartments

Aqueous Phase Ca, Mg, Ph, Na, Cl, CO2, casein proteins, whey

proteins (lactoalbumin, lactoferrin, IgA, lysozyme, albumin) Lactose, amino acids, water soluble vitamins

Colloidal Dispersion Caseins, Ca, Ph

Fat emulsion Fat (phospholipid, TG, cholesterol) protein as

fat globule membrane, enzymes, trace minerals, fat soluble vitamins, macrophages, neutrophils, lymphocytes

Preterm vs. Mature Human Milk

Increased nitrogen Increased fats (LCFA, MCFA, SCFA) Increased Na/Cl Increased Fe (?) Increased Mg No differences in energy, linolenic

acid, potassium, Ca, Ph, Cu, Zn, Vits B1-12, fat soluble vitamins

How is milk made?

Milk Synthesis Mammary gland contains stem

cells and highly differentiated secretory alveolar cells at the terminal ducts. Stimulated by insulin and HGH synergized by prolactin, these cells are active in milk synthesis and secretion

Milk synthesis and secretion Exocytosis (protein, lactose, Ca/Ph, citrate) Fat synthesis (TG synthesized in

cytoplasm and smooth endoplasmic reticulum + precursors imported from maternal circulation): alveolar cells synthesize SCFA

Secretion of ions and water Immunoglobins transferred from

extracellular spaces

Paracellular Pathway (5th process) The paracellular spaces between

alveolar cells normally prevent transfer secondary to tight junctions. If these spaces become “leaky” plasma constituents may pass directly into the milk.

Milk Synthesis and secretion Under neuroendocrine control that varies with

timing and stage of lactation Prolactin Lactogens Estrogen Thyroxine Growth hormone ACTH other

Stimulus: infant suckling

Milk synthesis Protein: vast majority of proteins

present in human milk are specific to mammary secretions and not identified in any quantity elsewhere in nature: Immunoglobins transferred from plasma

in early stages of lactation De novo protein synthesis by mammary

gland

Diet, milk production, and milk composition

There is a great variation in milk composition during a feed, from feed to feed, and even between breasts.

The impact of dietary variation and milk composition is unclear. Overall milk composition remains relatively unaffected by diet variations although there are reports to the contrary: DHA and ARA supplementation, vegan diet,

drugs and environmental contaminants,…..

Breast milk composition and Diet DHA levels of breast milk vary with diet.

Increased amounts of DHA have been found in the breast milk of mothers consuming fish or fish oil, and with supplementation.

Water soluble vitamins may vary with diet. Diets inadequate in B12 or thiamin have been associated with case reports of deficiency in infants. High intakes of Vitamin C, however, does not appear to change the content of breast milk.

Supplementation of fat soluble vitamins do not appear to alter the content of breast milk

Iron supplementation does not appear to alter the iron content of breast milk

Science and Lactation: Frank Hytten

“ In general, it is probable that the breast has a high priority for nutrients and that moderate maternal under nutrition will have little effect on milk production. But severe malnutrition, which rarely exists without associated ill-health and other adverse circumstances, may reduce milk yield”

Influence of diet on milk composition Protein-energy malnutrition impacts milk

volume. Composition remains relatively unaffected

Water soluble vitamins move readily from serum to milk thus dietary fluctuations are more apparent B12 vegan, case report of beriberi…..

Fat soluble vitamin content not improved with supplementation

Fatty acid composition (DHA and ARA) altered by maternal diet and supplementation

Distribution of Kcals: Breast milk

% Protein 6

% Fat 52

% Carbohydrate 42

Protein:Predominant protein of human milk is

whey. Casein/whey ratio is between 40:60 and 30:70

Casein: proteins of the curd (low solubility at pH 4.6) Whey: soluble proteins (remain soluble at pH 4.6)

LactalbuminLactoferrinSecretory IgALactoglobulin

Carbohydrate Predominant carbohydrate of

breast milk is lactose (7.3 g/dl) Oligosaccharides (1.2 g/dl)

Prebiotics: indigestible CHO that enhance the growth of “favorable” bacteria and contribute to the unique GI bacterial characteristics of BF infant (bifidobacteria)

Fat 2.5- 4.5% Fat (provides approx 50% of

calories) Contained in membrane enclosed milk

fat globules Core: TG (98-99%of total milk fat) Membrane: phospholipids,

cholesterol, protein DHA/ARA: wide variations

DHA/ARA concentration variation in human milk DHA: 0.1-1.4% ARA: 0.31- 0.71%

DHA lowest in populations with high meat intake and highest in populations with high fish intake

Breast milk and establishment of core microbiome Definition: Full collection of

microbes that naturally exist within the body.

Alterations or disruptions in core microbiome associated with chronic illness: Crohns disease, increased susceptibility to infection, allergy, NEC, etc

Microbiome Beneficial effect for the host:

Nutrient metabolism Tissue development Resistance to colonization with

pathogens Maintenance of intestinal homeostasis Immunological activation and

protection of GI integrity

Human milk and microbiome Core microbiome established soon

after birth Core microbiome of breastfeeding

infant similar to core microbiome of lactating mother

Components of breast milk supporting establishment of microbiome Prebiotics

AAP Policy Statement: Breastfeeding and the use of human milk: Pediatrics 115 #2 2005 Human milk is species specific and uniquely

superior for infant feeding Exclusive breastfeeding is the reference or

normative model against which all alternative methods must be measured in regards to growth, development and health

Research provides strong evidence that human milk feeding decreases the incidence and/or severity of a number of infectious diseases (meningitis, Otitis media, UTIs, Respiratory tract infections, NEC, diarrhea)

AAP Policy Statement: Breastfeeding and the use of human milk: Some studies suggest decreased incidence of

SIDS, diabetes (type 1 and 2), leukemia, obesity, hypercholesterolemia, and allergy (asthma and atopy)

Breastfeeding has been associated with slightly enhanced performance on tests of cognitive development.

AAP Policy Statement: Breastfeeding and the use of human milk AAP statement includes 15

recommendations on Breastfeeding healthy term infants including: Establish peripartum policies and

practices supporting breastfeeding Place infant skin to skin after delivery

until first feeding is accomplished

AAP Policy Statement:Recommendations continued

Supplements (water, glucose water, formula) should not be given unless medically indicated

Avoid pacifier during initiation 8-12 feedings at the breast every 24 hours

during early weeks All newborn breastfeeding infants should be

seen by HCP at 3-5 days and again at 2-3 weeks of age

All breast feeding infants should receive 200 (changed to 400) IU Vitamin D

1.Breast milk is an optimal source of nutrition for infants through the first year of life or longer. Those breastfeeding infants who develop symptoms of food allergy may benefit from: a.maternal restriction of cow's milk, egg,

fish, peanuts and tree nuts and if this is unsuccessful,

b.use of a hypoallergenic (extensively hydrolyzed or if allergic symptoms persist, a free amino acid-based formula) as an alternative to breastfeeding.

AAP: Breast milk and allergy

AAP Policy Statement: Breastfeeding and the use of human milk: Contraindications to breastfeeding

Galactosemia Maternal use/exposure to certain

radioactive or chemotherapeutic agents

Maternal abuse of “street drugs” Active HSV lesions of breast Maternal HIV (in USA)

Bright Futures AAP/HRSA/MCHB http://www.brightfutures.org “Bright Futures is a practical

development approach to providing health supervision for children of all ages from birth through adolescence.”

Newborn Visit: Breastfeeding Maternal care

rest fluids relieving breast engorgement caring for nipples eating properly

Follow-up support from the health professional by telephone, home visit, nurse visit, or early office visit.

Newborn Visit: Breastfeeding Infant Guidance

how to hold the baby and get him to latch on properly; feeding on cue 8-12 times a day for the first four to six

weeks; feeding until the infant seems content. Newborn breastfed babies should have six to eight wet

diapers per day, as well as several "mustardy" stools per day.

Give the breastfeeding infant 400 I.U.'s of vitamin D daily if he is deeply pigmented or does not receive enough sunlight.

Cautionary Tales Cooper et al. Pediatrics 1995. Increased

incidence of severe breastfeeding malnutrition and hypernatremia in a metropolitan area.

Rolf et al. ACTA Paediatrica 2009. A nationwide study on hospital admissions due to dehydration in exclusively breastfed infants in the Netherlands:its incidence, clinical characteristics, treatment and outcome

Lozoff et al. J Pediatrics 2009 Higher Infant Blood Levels with Longer Duration of Breastfeeding

Cooper. 5 breastfed infants admitted to Children’s

hospital in Cincinnati over 5 months period for breastfeeding malnutrition and dehydration

Age of admission: 5-14 days Weight loss at admission 23%, range 14-32% Serum Na: 186 mmol/L, range 161-214 (136-143 wnl) mothers were between the ages of 28 and 38, had

prepared for breastfeeding 3 had inverted nipples and reported latch-on problems

before discharge 3 families had contact with health care providers before

readmission including calls to PCP and home visit by PHN

Rolf Survey to determine incidence and

characteristics of hospital admission due to dehydration

Dutch Paediatric Surveillance Unit 2003-2005 of all hospital admissions during 1st 3 months in fully breast fed infants

250 reported cases. N= 158 (excluded cases with incomplete

information or co-existing medical conditions accounting for hospitalization

Rolf Incidence

40/y/10,000 < 11 days of age Overall incidence 48/y/10,000 < 3 months Severe dehydration 20/y/100,000

Characteristics in infants < 11 days Age at admission (mean/median) 3/5 Median weight loss: 9.3% Na range: 142-167 Other characteristics: lethargy, jaundice,

shock/seizures, evidence of inadequate intake via pre/post weights (67%)

Lozoff Our findings support the conclusions… “that

this phenomenon constitutes a potential public health problem in areas where environmental lead exposure is continuing as well as where environmental lead exposure has recently declined”… Our findings do not detract from the many known benefits of breastfeeding. Rather, they suggest that monitoring lead concentrations in breastfed infants should be considered….

Infant Feeding: Historical Perspective Human Milk Human Milk

Substitutes Science, Medicine

and Industry

Human Milk Substitutes Early evidence of artificial feeding Majority of infants received breast

milk Maternal BF Wet nurses

Wealthy women Orphans, abandoned, “illegitimate” Prematurity or congenital deformities

Wet Nurses Work demands, societal needs, vanity,

health requirements, social diversion Proper selection: Questionable

character-- Infant would suck in her vices

Wet Nurse Industry: emerging infant mortality/abuse

Impact of industrial revolution: Wet nurses made better money in factories

Human Milk Substitutes Milk from other mammals

(cow, goat, donkey, camel) Pablum: (bread and water)

“bread, water, flour, sugar and castille soap to aid digestion”

Beer Archeological findings, cows

horn, glass bottle shaped like horn, pap boat or pap spoon

Human Milk Substitutes: Infant Mortality Artificial feeding in first weeks of

life associated with 100% mortality 19th century infant mortality with

“hand feeding” was 88% Foundlings: 80% In Dublin Foundling hospital 1775-

96: 99.6%

Science, Medicine, and Industry

Growth of child Health and welfare in early 20th century

Science, Medicine, and Industry Infant Morbidity and

Mortality Recognition of

association with human milk substitutes, and infection

Industrial development Storage Safety Food industry

Historical timeline 1900

Pasteurization of milk in US

Association between bacteria and diarrhea

1912 U.S Children’s Bureau Public Health and

Pediatricians efforts to improve infant/child health and decrease mortality

1920 Intro evaporated milk Cod liver oil prevents

rickets Curd tension of milk

altered Increased availability

of refrigeration Vitamin C isolated Vitamin D prepared in

pure form Improved sanitation

Infant Formulas - History Cow’s milk is high in protein, low in

CHO, results in large initial curd formation in gut if not heated before feeding

Early Formulas from 1920-1950 majority of non-breastfed infants

received evaporated milk formulas boiled or evaporated milk solved curd formation problems

CHO provided by corn syrup or other cho to decrease relative protein kcals

Human Milk Substitutes 1920-1950’s: evaporated or fresh

cow’s milk, water and added CHO (prepared at home)

1950’s to present commercially prepared infant formulas have replaced home recipes

Historical timeline

1940 Homogenized milk

widely marketed

1960 Further advances in

technology and packaging

Commercially prepared infant formula becoming increasingly popular

Infant Formula - History, cont. 50s and 60s commercial formulas

replaced home preparation 1959: iron fortification introduced, but

in 1971 only 25% of infants were fed Fe fortified formula

Cow’s milk feedings started in middle of first year between 1950-1970s. In 1970 almost 70% of infants were receiving cow’s milk.

Interesting Milestones in Infant Nutrition 1784: Underwood

recommends cows milk as alternative to breast feeding

1800: glass feeding bottles

1838: Simon determines protein CM>BM

1845: Pratt patents rubber nipple

1856: Borden patents condensed milk

1883: Meyenberg patents evaporated goats milk

1885: Meigs analyses human milk

Interesting Milestones in Infant Nutrition

1911: MJ introduces Dextri-maltose 1915: SMA 1920: Franklyn (Similac) 1929: MJ markets Sobee, hypoallergenic 1930-60: Concentrated liquid, hydrolysed,

elemental, and ready to feed formulas introduced

What now?

Formula

Formula Composition Breast Milk as “gold standard”

Attempt to duplicate composition of breastmilk

? Bioactivity, relationship, function of all factors present in breast milk

? Measure outcome: growth, composition, functional indices

Formula Brands Ross

Similac/Isomil/Alimentum Mead Johnson

Enfamil/Prosobee/Enfacare Nestle

Good Start Wyeth

Generic in USA; Gold Brands; SMA SHS

NeoCate, DuoCal

Distribution of Kcals Formula

% Protein 9

% Fat 48

% Carbohydrate 42

Vitamin and Mineral content NAS/FDA Meet levels at typical volumes

ingested by infants (@ 24-32 ounces) i.e. RDA/DRI

Standard Infant Formulas, Milk or Soy Based………..

Cow’s Milk Based Formula Commercial formula designed to

approximate nutrients provided in human milk

Some nutrients added at higher levels due to less complete digestion and absorption

Milk Based Formulas Standard 0-12

months Similac with iron Enfamil with iron Good Start

Essentials/Good Start Supreme

Wyeth Generic

Standard 0-12 mos with DHA/ARA Similac Advance

with iron Enfamil Lipil with

iron Good Start

Supreme DHA/ARA Wyeth formulas

Protein Blend of whey and

casein proteins 8.2-9.6% total

calories

whey proteins of human and cow’s milk are different and have different amino acid profiles.

Major whey proteins of human milk are lactalbumin (high levels of essential aa) , immunoglobulins, and lactoferrin( enhances iron transportation)

Cow’s milk has low levels of these proteins and high levels of b lactoglobulin

Cow’s Milk Based Formula: Fat & CHO Fat: butterfat of cow’s milk is replaced

with vegetable fat sources to make the fatty acid profile of cow’s milk formulas more like those of human milk and to increase the proportion of essential fatty acids

CHO: Lactose is the major carbohydrate in most cows’ milk based formulas.

Meets needs of healthy infants

Milk Based Pre and Probiotic Supplemented Marketed to promote digestive health

and support healthy immune fx Probiotic

Bifidus BL Gerber Good start Protect Plus

Lactobacillus rhamosus Nutramigen Lipil with Enflora

Prebiotic Galactooligosaccarides (GOS) Similac Advance Early Shield (Triple Shield),

Enfamil Premium, Generic Brands

Infant Formulas: AAP Cow’s milk based formula is

recommended for the first 12 months if breast milk is not available

Soy Formulas First developed in 1930s with soy

flour Early formulas produced diarrhea

and excessive gas Now use soy protein isolate with

added methionine

Soy Formulas Isomil/Isomil DF /Isomil

Advance/Isomil Advance 2 Prosobee/Prosobee Lipil/Next

Step Prosobee Good Start Essentials Soy/Good

Start 2 Essentials Soy Wyeth All iron fortified

Soy Formulas Protein: soy protein isolate with

added methionine Fat: vegetables oils CHO: usually corn based products

Soy FormulasCharacteristics compared to Milk

Based

Higher protein (lower quality) Higher sodium, calcium, and

phosphorus Carbohydrate: Corn syrup solids,

sucrose, and/or maltodextrin; lactose free

Fats: Long chain Meet needs of healthy infants

American Academy of Pediatrics Committee on Nutrition. Soy Protein-based Formulas: Recommendations for Use in Infant Feeding. Pediatrics 1998;101:148-153.

Soy formulas given to 25% of infants but needed by very few

Offers no advantage over cow milk protein based formula as a supplement for breastfed infants

Provides appropriate nutrition for normal growth and development

Indicated primarily in the case of vegetarian families and for the very small number of infants with galactosemia and hereditary lactase deficiency

Possible Concerns about Soy Formulas: AAP 60% of infants with cowmilk protein induced

enterocolitis will also be sensitive to soy protein - damaged mucosa allows increased uptake of antigen.

Contains phytates and fiber oligosacharides so will inhibit absorption of minerals (additional Ca is added)

Higher levels of osteopenia in preterm infants given soy formulas

Phytoestrogens at levels that demonstrate physiologic activity in rodent models

Higher aluminum levels

Health Consequences of Early Soy Consumption. Badger et al. J Nutr. 2002

US soy formulas made with soy protein isolate (SPI+)

SPI+ has several phytochemicals, including isoflavones

Isoflavones are referred to as phytoestrogens Phytoestrogens bind to estrogen receptors &

act as estrogen agonists, antagonists, or selective estrogen receptor modulators depending on tissue, cell type, hormonal status, age, etc.

Figure 1. Hypothetical serum concentrations profile of isoflavones from conception through weaning in typical Asians and Americans. The values represent the range of isoflavonoids reported by Adlercreutz et al. (6 ) for Japanese (dotted lines) or reported by Setchell et al. (3 ) for Americans fed soy infant formula (dashed line).

Should we be Concerned? - Badger et al. No human data support toxicity of

soyfoods Soyfoods have a long history in Asia Millions of American infants have been

fed soy formula over the past 3 decades Rat studies indicate a potential

protective effect of soy in infancy for cancer

Contraindications to Soy Formula: AAP

preterm infants due to increased risk of inadequate bone mineralization

infants with cow milk protein-induced enteropathy or enterocolitis

most previously well infants with acute gastroenteritis

prevention of colic or allergy.

Soy formula for prevention of allergy and food intolerance in infants (Cochrane, 2006) “Feeding with a soy formula cannot be

recommended for prevention of allergy or food intolerance in infants at high risk of allergy or food intolerance. Further research may be warranted to determine the role of soy formulas for prevention of allergy or food intolerance in infants unable to be breast fed with a strong family history of allergy or cow's milk protein intolerance.”

Predigested protein based infant formulas

Protein Hydrolysate Formulas Alimentum Advance Pregestimil/Pregestimil Lipil Nutramigen Lipil

Protein Casein hyrolysate + free AA’s Fat (Alimentum and Pregestimil) Medium

chain + Long chain triglycerides;(Nutramigen) Long chain triglycerides

Carbohydrate: Lactose free

Hydrolysate Formulas Whey Hydrolysate Formula: Cow’s milk

based formula in which the protein is provided as whey proteins that have been hydrolyzed to smaller protein fractions, primarily peptides. This formula may provoke an allergic response in infants with cow’s milk protein allergy.

Casein Hydrolysate Formula: Infant formula based on hydrolyzed casein protein, produced by partially breaking down the casein into smaller peptide fragments and amino acids. `

Cow’s milk protein avoidance and development of childhood wheeze in children with a family history of atopy(Cochrane, 2003)

Breast-milk should remain the feed of choice for all babies.

In infants with at least one first degree relative with atopy, hydrolysed formula for a minimum of four months combined with dietary restrictions and environment measures may reduce the risk of developing asthma or wheeze in the first year of life.

There is insufficient evidence to suggest that soya-based milk formula has any benefit.

Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants (2006) There is no evidence to support feeding with a

hydrolysed formula for the prevention of allergy compared to exclusive breast feeding. In high risk infants who are unable to be completely breast fed, there is limited evidence that prolonged feeding with a hydrolysed formula compared to a cow's milk formula reduces infant and childhood allergy and infant cow’s milk allergy. In view of methodological concerns and inconsistency of findings, further large, well designed trials comparing formulas containing partially hydrolysed whey, or extensively hydrolysed casein to cow's milk formulas are needed.

AAP Policy Statement Re: Hypoallergenic Infant Formulas (August, 2000)

Recommendations

AAP Policy Statement Re: Hypoallergenic Infant Formulas (August, 2000) Currently available, partially

hydrolyzed formulas are not hypoallergenic.

2.Formula-fed infants with confirmed cow's milk allergy may benefit from the use of a hypoallergenic or soy formula as described for the breastfed infant.

3.Infants at high risk for developing allergy, identified by a strong (biparental; parent, and sibling) family history of allergy may benefit from exclusive breastfeeding or a hypoallergenic formula or possibly a partial hydrolysate formula. Conclusive studies are not yet available to permit definitive recommendations. However, the following recommendations seem reasonable at this time:

AAP Policy Statement Re: Hypoallergenic Infant Formulas (August, 2000) Carefully conducted randomized controlled

studies in infants from families with a history of allergy must be performed to support a formula claim for allergy prevention. Allergic responses must be established prospectively, evaluated with validated scoring systems, and confirmed by double-blind,placebo-controlled challenge. These studies should continue for at least 18 months and preferably for 60 to 72 months or longer where possible

Elemental formula for infants

Amino Acid Based Formulas

Elecare, Neocate, Nutramigen AA Protein: Free Amino Acids Fat: Long chain and medium chain

Elecare (33% MCT), Neocate (5% MCT) Carbohydrate: corn syrup solids,

Lactose and sucrose free Indications for use: Food Allergy or

intolerance to peptides or whole protein

Elemental Infant Formula

NeoCate (SHS) Protein: Free Amino Acids Fat: Long chain Carbohydrate: Lactose Free Indications for use: Food Allergy

or intolerance to peptides or whole protein

Other Specialty Formulas Portagen (Mead Johnson)

85% fat MCT, 15% fat Corn oil Used for infants with chylothorax

Similac PM 60/40 (Ross) Low in Ca, P, K+ and NA; 2:1 Ca:P ratio Used for infants with Renal Failure

Formulas for Metabolic Disorders Several condition specific products by

Ross and Mead Johnson

Premature FormulasGeneral Characteristics compared to

Standard

Increased Protein,Vitamins & Minerals For infants born at <1.5kg

up to 2000-2500gm Feeding of infants > 2500 gm

risk of vitamin toxicities Premature formulas vary in nutrient

content

Premature Formula Standard Infant Formula

Protein: Whey Predominant

Protein: Whey or Casein predominant

CHO: Lactose and Glucose Polymers

CHO: Lactose

Fat: Medium and Long chain TG

Fat: Long chain TG

Higher concentration of vitamins and minerals

Meets term vitamin and mineral guidelines at 24-32 oz

Iso-osmolar Iso-osmolar

Premature Infant Breast Milk Additives and

Formulas Enfamil Human Milk Fortifier Similac Human Milk Fortifier

Powdered breast milk additives Similac Natural Care Advance

Liquid breast milk additive Similac Special Care Advance Enfamil Premature +/- Lipil

Post Premature Infant formula

“Post” Premature Formulas

NeoSure Advance EnfaCare Lipil

Standard Dilution: 22 kcal/oz Protein: between standard and Premature Vitamins: Higher than

standard,significantly lower than Premature Calcium and Phosphorus: between

standard and Premature

Formulas with DHA & ARARoss Mead Johnson

Full term SimilacAdvance

Enfamil Lipil

Preterm Similac SpecialCare, SimilacNatural Care,NeoSureAdvance

EnfamilPrematureLipil,EnfacareLipil

Indications Cow’s milk based

Health term infant Soy

Vegetarian Galactosemia

Protein Hydrolysates Protein intolerance/allergy other

Preterm Formulas Post-discharge Preterm formulas Other Specialty Formulas

Specific medical, metabolic indications

Know What You Are Feeding Caloric density, protein, fat and carbohydrate vitamin and

mineral content. Osmolality: Renal Solute Load: Evaluate RSL in context of solute

intake, fluid intake and output. Evidence Based Rationale Cost and availability

Finding Up to Date Information

www.ross.com Similac products www.meadjohnson.com Enfamil products www.verybestbaby.com Nestle products www.wyethnutritionals.com generic products

www.brightbeginnings.com lower cost formulas made by Wyeth

www.shsna.com/html/Hypoallergenic.htmNeocate formulas

Regulation of Infant Formula FDA

Infant Formula Act Manufacturers

Voluntary monitoring AAP, National Academy of Sciences, other

professional organizations Guidelines for composition and intake: (e.g.

DRI’s) Guidelines for preparation and handling of

formula/human milk in health care facilities

Regulation of Infant Formulas Infant Formula Act:

Manufacturing regulations Quality control

Non specific testing requirements, case by case basis, growth outcomes

Recall Proceedures Nutrient content and labeling Panel convened 1998 and 2002

(recommended revisions including exemptions)

Regulation of Infant Formulas Infant Formula Act: The purpose of the infant

formula act (1980) is to ensure the safety and nutrition of infant formulas – including minimum and in some cases maximum levels of specified nutrients. The act authorizes the FDA to establish appropriate regulations for 1) new formulas, 2) formulas entering the U.S. market, 3) major changes, revisions, or substitutions of macronutrients 4) formulas manufactured in new plants or processing lines, 5) addition of new constituents 6) use of new equipment or technology 7) packaging changes

Formula Regulation Regulation is by the Infant Formula Act

of 1980, under FDA authority Nutrient composition guidelines for 29

nutrients established by AAP Committee on Nutrition and adopted as regs by FDA

Nutrient Requirements for Infant Formulas. Federal Register 36, 23553-23556. 1985. 21 CFR Part 107.

Infant Formula Act Institute of Medicine Food and Nutrition

Board 3/2004 “Although the federal regulatory processes

for evaluating the safety of food ingredients have worked well for conventional substances, they were not designed to ensure the needs and vulnerabilities of infants and are insufficient to ensure the safety of new types of ingredients proposed for infant formulas

Infant Formula Act “The current regulatory processed do not

fully address the unique role of formula as a food source. Formula is the only infants’ food if they are not being breastfed. The processes used to regulate the safety of any new additions of formula should be tailored to these products distict role and the special needs and susceptibilities of infants”

Infant Formula Act Key limitation: lack of explicit

guideleines for determining when and what safety data is needed…..(GRAS)

Clarification is crucial given the increasing number of bioactive peptides and enzymens generated from unconventional sources or new technologies

Infant Formula Act: Points for discussion Addition of DHA and ARA to

formulas Addition of prebiotics to formula

Present in BM GRAS Vitamin/mineral content conforms to

regulation ? testing

Formula Safety Issues - 2002 Enterobacter Sakazakii in Intensive care

units Powered formula is not sterile so should

not be used with high risk infants FDA recommends mixing with boiling

water but this may affect availability of vitamins & proteins and also cause clumping

Irradiation proposed

Formula safety FDA recall list 2005-2006

Formula Safety Infant Feedings: Guidelines for

Preparation of Formula and Breastmilk in Health Care Facilities: Pediatric Nutrition Practice Group of ADA 2003

AAP AHA ANA FDA CDC others

Milk Feedings Cautionary Tales

Keating et al. AJDC 1991. Oral water intoxication in infants.

Lucas et al. Arch Dis Child. 1992. Randomized trial of ready to fed compared with powdered formula.

Keating 24 cases of oral water intoxication in 3

years at Children’s Hospital and St. Louis

Most were from very low income families and were offered water at home when formula ran out

Authors suggest: provision of adequate formula and anticipatory guidance

Lucas 43 infants randomized to RTF or powdered

formula Infants given powdered formula had increased

body wt. And skinfold thickness at 3 and 6 mos.. Compared to RTF and breastfed

Powdered formula - 6 of 19 were above the 90th percentile wt/ht, but only 1 of 19 RTF infants

Authors suggest errors in reconstitution of formula

Formula Safety

Iron and Breastmilk Powdered products in at-risk

populations Non sterile Recommend against use unless no

other alternative

Bright Futures AAP/HRSA/MCHB http://www.brightfutures.org “Bright Futures is a practical

development approach to providing health supervision for children of all ages from birth through adolescence.”

Additional concerns/issues

Appropriate infant feeding Cows milk, goats milk, homemade

formulas safety Preparation: mixing, storing, warming

(microwave) miscellaneous

Formula Safety

Separate room for mixing Aseptic conditions Gram scale, appropriately

calibrated measuring tools Standardized recipes Temperature, hang time etc

Cows milk and goats milk Protein RSL Folic acid, iron, vitamin D pasteurization

AAP: Cow’s Milk in Infancy Objections include:

Cow’s milk poor source of iron GI blood loss may continue past 6 months Bovine milk protein and Ca inhibit Fe

absorption Increased risk of hypernatremic dehydration

with illness Limited essential fatty acids, vitamin C, zinc Excessive protein intake with low fat milks

Newborn Visit: Bottle-feeding type of formula, preparation feeding techniques, and equipment. Hold baby in semi-sitting position to feed. Do not use a microwave oven to heat

formula. To avoid developing a habit that will harm your infant's teeth, do not put him to bed with a bottle or prop it in his mouth.