Formula 09

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

“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 Colostrum

Higher concentration of protein and antibodies

Transitions around days 3-5 Mature by day 10

Distribution of KcalsBreastmilk Formula

% Protein 6 9

% Fat 52 48

% Carbohydrate 42 42

Protein:Predominant protein of human milk is whey &

predominant protein in cow’s milk is casein Casein: proteins of the curd (low solubility at

pH 4.6) Whey: soluble proteins (remain soluble at pH

4.6) Ratio of casein to whey is between 40:60 and

30:70 in human milk and 82:18 in cow’s milk some formulas provide more whey proteins

than others

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

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

Fatty Acid, etc Cost Other

Breastmilk 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 susceptability 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 breastmilk supporting establishment of microbiome Prebiotics,probiotics

Allergies: Breastmilk May be protective due to sIgA and

mucosal growth factors Maternal avoidance diets in

lactation remain speculative. May be useful for some highly motivated families with attention to maternal nutrient adequacy.

AAP: Breastfeeding and the Use of Human Milk, 1997 “Exclusive breastfeeding is ideal

nutrition and sufficient to support optimal growth and development for approximately the first 6 months after birth….It is recommended that breastfeeding continue for at least 12 months, and thereafter for as long as mutually desired.”

AAP: Breastfeeding and the Use of Human Milk, 1997 Human milk is the preferred feeding

for all infants Breastfeeding should begin as soon

as possible after birth Newborns should be nursed 8 to 12

times every 24 hours until satiety, usually 10 to 15 minutes per breast. (Crying is a late indicator of hunger.)

AAP: Breastfeeding and the Use of Human Milk, 1997 “Should hospitalization of the

breastfeeding mother or infant be necessary, every effort should be made to maintain breastfeeding preferably directly or by pumping the breasts.”

AAP: Breastfeeding and the Use of Human Milk, 1997 Formal evaluation of breastfeeding by

trained observers at 24-48 hours and again at 48 to 72 hours.

No supplements should be given unless a medical indication exists.

When discharged at <48 hours, should have FU visit at 2 to 4 days of age, assessment at 5 to 7 days, and be seen at one month.

AAP statement on breastfeeding (continued) Supplements (water, glucose,

formula) should be avoided (unless medically necessary). Pacifiers should also be avoided.

Exclusive breastfeeding is ideal for the first 6 months. Breastfeeding should continue for at least 12 months.

AAP statement on breastfeeding (continued) In the first 6 months, water, juice

and other foods are generally unnecessary. Vitamin D and iron may be needed. Fluoride should not be given during the first 6 months.

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

Breast feeding and allergya.Breastfeeding mothers should continue breastfeeding

for the first year of life or longer. During this time, for infants at risk, hypoallergenic formulas can be used to supplement breastfeeding. Mothers should eliminate peanuts and tree nuts (eg, almonds, walnuts, etc) and consider eliminating eggs, cow's milk, fish, and perhaps other foods from their diets while nursing. Solid foods should not be introduced into the diet of high-risk infants until 6 months of age, with dairy products delayed until 1 year, eggs until 2 years, and peanuts, nuts, and fish until 3 years of age.

Infant Feeding: Historical Perspective Breast feeding 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

Human Milk Substitutes Wet nurses Other mammalian milk (cow, goat,

donkey, camel) Pablum: bread/flour, mixed with

water “bread, water, flour, sugar and

castille soap to aid digestion”

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

Historical timeline

1940 Homogenized milk

widely marketed

1960 Further advances in

technology and packaging

Commercially prepared infant formula becoming increasingly popular

Human Milk Substitutes 1915 Gerstenberger

developed first “complete infant formula” marketed as SMA (synthetic milk adapted) Base was defatted and diluted

cow’s milk with beef tallow added to mimic the fat content of human milk

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

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.

INFANT 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

Infant Formula: Categories Term vs. Preterm Standard Infant Formula

Cows Milk Based Soy Formula

Specialty Formulas Hypoallergenic: Peptide hydrolysates, amino acid

based Metabolic Products other

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

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

Milk Based FormulasCharacteristics

Blend of Whey and Casein Proteins (8.2-9.6 % total calories)

Carbohydrate: lactose Fats: long chain Meet needs of healthy infant

Standard Infant Formula DHA/ARA Prebiotics/Probiotics Fiber Organic Other

Advance, Lipil, Gentlease, Restful, Sensitive, Early Shield, Triple Guard….etc, etc

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 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

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).

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.

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

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.”

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.

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. `

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.

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) 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

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:

Elemental formula for infants

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 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

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

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

Feeding the Infant Considerations

Infant (needs, tolerance, acceptance, safety)

Indications Family preferences Cost availability

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

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

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

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.

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

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)

Formula safety FDA recall list 2005-2006

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

Addition of DHA & ARA 2001: FDA approves as GRAS 2002: Ross & Mead Johnson

introduce products with DHA and ARA

Cost: 15-20% above standard formulas

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

Additional concerns/issues

Inappropriate infant feeding Cows milk, goats milk, homemade

formulas safety Preparation miscellaneous

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

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

Milk Feedings Cautionary Tales

Cooper et al. Pediatrics 1995. Increased incidence of severe breastfeeding malnutrition and hypernatremia in a metropolitan area.

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.

Cooper, cont. 5 breastfed infants admitted to Children’s

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

age at readmission was 5 to 14 days 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

Cooper, cont. at time of readmit none of presenting

complaints related to s&s of dehydration, only one infant presented with feeding complaint

wt. Loss at admission: 23%, range 14-32% Serum Na - mean 186 mmol/l, range 161-214

(136-143 is wnl) 3 infants had severe complications: multiple

cerebral infarctions, left leg amputation secondary to iliac artery thrombus

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 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 Preparation Microwave Protocol (Sigman-Grant,

1992) Heat only 4 oz or more refrigerated

formula with bottle top uncovered 4 oz bottles < 30 seconds 8 oz bottles < 45 seconds Invert 10 times before use Should be cool to the touch Always test drops of formula on

tongue or top of hand

Breast Milk: Environmental contamination Lozoff et al Higher Blood Lead

Levels with Longer Duration of Breastfeeding J. Pediatr 2009:159:663-667

Gundacker, et al Lead and Mercury in Breast milk Pediatrics 2002 110:873-8

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 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.

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: 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.

First Week Do not give the infant honey until after

her first birthday to prevent infant botulism.

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

One Month Delay the introduction of solid foods

until the infant is four to six months of age. Do not put cereal in a bottle.

Four Months Continue to breastfeed or to use iron-

fortified formula for the first year of the infant's life. This milk will continue to be his major source of nutrition.

Begin introducing solid foods with a spoon when the infant is four to six months of age.

Use a spoon to give him an iron-fortified, single-grain cereal such as rice.

Four Months, cont. If there are no adverse reactions, add a new pureed

food to the infant's diet each week, beginning with fruits and vegetables.

Always supervise the infant while he is eating. Give exclusively breastfeeding infants iron

supplements. Continue to give the breastfeeding infant 400 I.U.'s

of vitamin D daily if he is deeply pigmented or does not receive enough sunlight.

Do not give the infant honey until after his first birthday to prevent infant botulism. .

Six Months, cont. Let the infant indicate when and how

much she wants to eat. Serve solid food two or three times per

day. Begin to offer a cup for water or juice. Limit juice to four to six ounces per day. Give iron supplements to infants who

are exclusively breastfeeding.

Ben Age: 4 day old. Term breastfed

male Birth weight 3.2 kg Current weight: 2.8 kg Maternal concern: milk supply

Kali 3 month old female, referred for FTT Weight gain over the past month 3 g/d Weight decreased from 70th percentile

at birth, to 10th percentile “colicky” Formula: Soy formula