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 Kcals
Breastmilk
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.
AAP: Breast milk and allergy

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 acidbased formula) as an alternative to breastfeeding.
Breast feeding and allergy
a.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


Mead Johnson


Good Start
Wyeth


Enfamil/Prosobee/Enfacare
Nestle


Similac/Isomil/Alimentum
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
Milk Based Formulas
Characteristics

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 Formulas
Characteristics 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
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



Similac PM 60/40 (Ross)



(Mead Johnson)
85% fat MCT, 15% fat Corn oil
Used for infants with chylothorax
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 Formulas
General Characteristics compared to Standard

Increased Protein,Vitamins &
Minerals

For infants born at <1.5kg


Feeding of infants > 2500 gm


up to 2000-2500gm
risk of vitamin toxicities
Premature formulas vary in nutrient
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


Soy






Vegetarian
Galactosemia
Protein Hydrolysates


Health term infant
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.htm
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 ironfortified 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