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 professors
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:
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)

Lactalbumin
Lactoferrin
Secretory IgA
Lactoglobulin

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

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 acid-based formula) as an
alternative to breastfeeding.

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 Childrens

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 177596: 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 Childrens 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

Cows 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

1920-1950s: evaporated or fresh

cows milk, water and added CHO
(prepared at home)
1950s 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
Cows milk feedings started in middle of
first year between 1950-1970s. In 1970
almost 70% of infants were receiving
cows 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

Mead Johnson

Good Start

Wyeth

Enfamil/Prosobee/Enfacare

Nestle

Similac/Isomil/Alimentum

Generic in USA; Gold Brands; SMA

SHS

NeoCate, DuoCal

Distribution of Kcals

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..

Cows 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 cows 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)
Cows milk has low
levels of these proteins
and high levels of b
lactoglobulin

Cows Milk Based Formula: Fat &

CHO

Fat: butterfat of cows milk is replaced

with vegetable fat sources to make the
fatty acid profile of cows 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

Lactobacillus rhamosus

Gerber Good start Protect Plus

Nutramigen Lipil with Enflora

Prebiotic

Galactooligosaccarides (GOS)
Similac Advance Early Shield (Triple Shield),
Enfamil Premium, Generic Brands

Infant Formulas: AAP

Cows 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 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

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 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. `

Cows 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 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)
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

Similac PM 60/40

Formulas for Metabolic Disorders

(Mead Johnson)
85% fat MCT, 15% fat Corn oil
Used for infants with chylothorax
(Ross)
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 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

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 & ARA

Ross

Mead Johnson

Full term

Similac
Advance

Enfamil Lipil

Preterm

Similac Special
Care, Similac
Natural Care,
NeoSure
Advance

Enfamil
Premature
Lipil,
Enfacare
Lipil

Indications

Cows 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

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.htm
Neocate 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.
DRIs)
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, 2355323556. 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 Childrens 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: 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
absorption
Increased risk of hypernatremic dehydration
with illness
Limited essential fatty acids, vitamin C, zinc
Excessive protein intake with low fat milks

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
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.