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Infant Feeding: Human

Milk and Formula Joan C

Zerzan MS RD CD

No two hemispheres of
any learned professors
brain are equal to two
healthy mammary
glands in the production
of a satisfactory food for
- Oliver Wendell Holmes

Human Milk


Higher concentration of protein and

Transitions around days 3-5
Mature by day 10

Distribution of Kcals


% Protein

% Fat



% Carbohydrate



Predominant protein of human milk is whey &
predominant protein in cows milk is casein
Casein: proteins of the curd (low solubility at
pH 4.6)
Whey: soluble proteins (remain soluble at pH
Ratio of casein to whey is between 40:60 and
30:70 in human milk and 82:18 in cows 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

Breastmilk and
establishment of core

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


Beneficial effect for the host:

Nutrient metabolism
Tissue development
Resistance to colonization with
Maintenance of intestinal homeostasis
Immunological activation and
protection of GI integrity

Human milk and


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


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,

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,

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,

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,
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

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

AAP: Breast milk and


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
a.maternal restriction of cow's milk, egg,
fish, peanuts and tree nuts and if this is
b.use of a hypoallergenic (extensively
hydrolyzed or if allergic symptoms persist, a
free amino acid-based 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


Breast feeding
Human Milk
Science, Medicine
and Industry

Human Milk Substitutes

Early evidence of artificial feeding

Majority of infants received breast

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

bread, water, flour, sugar and

castille soap to aid digestion

Historical timeline

Pasteurization of milk
in US
Association between
bacteria and diarrhea
U.S Childrens Bureau
Public Health and
Pediatricians efforts
to improve
infant/child health
and decrease

Intro evaporated milk
Cod liver oil prevents
Curd tension of milk
Increased availability
of refrigeration
Vitamin C isolated
Vitamin D prepared in
pure form
Improved sanitation

Historical timeline


Homogenized milk
widely marketed


Further advances in
technology and
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

cows milk with beef tallow added
to mimic the fat content of human

Infant Formulas - History

Cows milk is high in protein, low in

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


50s and 60s commercial formulas

replaced home preparation
1959: iron fortification introduced, but
in 1971 only 25% of infants were fed Fe
fortified formula
Cows milk feedings started in middle of
first year between 1950-1970s. In 1970
almost 70% of infants were receiving
cows milk.


Formula Composition

Breast Milk as gold standard

Attempt to duplicate composition of

? Bioactivity, relationship, function of
all factors present in breast milk
? Measure outcome: growth,
composition, functional indices

Formula Brands


Mead Johnson

Good Start





Generic in USA; Gold Brands; SMA


NeoCate, DuoCal

Infant Formula: Categories

Term vs. Preterm

Standard Infant Formula
Cows Milk Based
Soy Formula
Specialty Formulas
Hypoallergenic: Peptide hydrolysates, amino acid
Metabolic Products

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 Formulas


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


Advance, Lipil, Gentlease, Restful,

Sensitive, Early Shield, Triple
Guard.etc, etc

Infant Formulas: AAP

Cows milk based formula is

recommended for the first 12
months if breast milk is not

Soy Formulas

First developed in 1930s with soy

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
Higher protein (lower quality)
Higher sodium, calcium, and
Carbohydrate: Corn syrup solids,

sucrose, and/or maltodextrin; lactose


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
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+ has several phytochemicals, including
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 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

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
Alimentum Advance
Pregestimil/Pregestimil Lipil
Nutramigen Lipil

Protein Casein hyrolysate + free AAs

Fat (Alimentum and Pregestimil) Medium

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

Carbohydrate: Lactose free

Hydrolysate Formulas

Whey Hydrolysate Formula: Cows 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 cows 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)

AAP Policy Statement Re:

Hypoallergenic Infant Formulas
(August, 2000)

Currently available, partially

hydrolyzed formulas are not

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 cows 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


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


Similac PM 60/40

Formulas for Metabolic Disorders

(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

Several condition specific products by

Ross and Mead Johnson

Premature Infant Breast

Milk Additives and
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

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


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


Infant (needs, tolerance,

acceptance, safety)
Family preferences

Know What You Are Feeding

Caloric density, protein, fat and carbohydrate vitamin and

mineral content.
Renal Solute Load: Evaluate RSL in context of solute
intake, fluid intake and output.

Evidence Based


Cost and availability


Cows milk based



Protein Hydrolysates

Health term infant

Protein intolerance/allergy

Preterm Formulas
Post-discharge Preterm formulas
Other Specialty Formulas

Specific medical, metabolic indications

Regulation of Infant

Infant Formula Act
Voluntary monitoring
AAP, National Academy of Sciences,
other professional organizations
Guidelines for composition and
intake: (e.g. DRIs)
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, 2355323556. 1985. 21 CFR Part 107.

Regulation of Infant

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

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

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

Infant Formula Act: Points

for discussion

Addition of DHA and ARA to

Addition of prebiotics to formula

Present in BM
Vitamin/mineral content conforms to
? testing

Addition of DHA & ARA

2001: FDA approves as GRAS

2002: Ross & Mead Johnson
introduce products with DHA and
Cost: 15-20% above standard

Finding Up to Date
Information Similac products Enfamil products Nestle products generic products lower cost formulas

made by Wyeth
Neocate formulas

Additional concerns/issues

Inappropriate infant feeding

Cows milk, goats milk, homemade



AAP: Cows Milk in Infancy

Objections include:

Cows milk poor source of iron

GI blood loss may continue past 6 months
Bovine milk protein and Ca inhibit Fe
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

Folic acid, iron, vitamin D

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 Childrens

hospital in Cincinnati over 5 months period
for breastfeeding malnutrition and

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


24 cases of oral water intoxication in 3

years at Childrens Hospital and St.
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


43 infants randomized to RTF or powdered

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
Authors suggest errors in reconstitution of

Formula Safety Issues - 2002

Enterobacter Sakazakii in Intensive care

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
Irradiation proposed

Formula Preparation
Microwave Protocol (Sigman-Grant,

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


Lozoff et al Higher Blood Lead

Levels with Longer Duration of
Breastfeeding J. Pediatr
Gundacker, et al Lead and Mercury
in Breast milk Pediatrics 2002

Bright Futures

Bright Futures is a practical
development approach to
providing health supervision for
children of all ages from birth
through adolescence.

Newborn Visit:

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
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:

Maternal care

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: Bottlefeeding

type of formula, preparation

feeding techniques, and equipment.
Hold baby in semi-sitting position to feed.
Do not use a microwave oven to heat
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
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

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
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
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.


Age: 4 day old. Term breastfed

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


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
Formula: Soy formula