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

Infant Feeding: Human Milk
and Formula Joan C Zerzan MS RD CD
Infant Feeding: Historical
Perspective

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Human Milk
Human Milk
Substitutes
Science, Medicine
and Industry
Feeding the Infant
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Considerations
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Infant (needs, tolerance,
acceptance, safety)
Family preferences
Cost and availability
Prevention, health,
development, and
programming
Feeding the Infant
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Choices:
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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
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“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
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Complements infant Immaturity
Promotes maturation
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Epithelial growth factors and hormones
Digestive enzymes - lipases and amylase
Characteristics and
Advantages of Human Milk
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Low renal solute load
Immunologic, growth and trophic factors
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Decrease illness, infection, allergy
Improved digestion and absorption
Nutrient Composition: CHO, Protein, Fatty
Acid, etc
Cost
Other
Human Milk
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Colostrum
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Higher concentration of protein and
antibodies
Transitions around days 3-5
Mature by day 10
Human Milk
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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
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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
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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
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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
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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
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Secretion of ions and water
Immunoglobins transferred from
extracellular spaces
Paracellular Pathway (5th process)
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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
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Under neuroendocrine control that varies with timing
and stage of lactation
 Prolactin
 Lactogens
 Estrogen
 Thyroxine
 Growth hormone
 ACTH
 other
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Stimulus: infant suckling
Milk synthesis
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Protein: vast majority of proteins
present in human milk are specific to
mammary secretions and not identified
in any quantity elsewhere in nature:
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Immunoglobins transferred from plasma in
early stages of lactation
De novo protein synthesis by mammary
gland
Diet, milk production, and milk
composition
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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:
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DHA and ARA supplementation, vegan diet, drugs
and environmental contaminants,…..
Breast milk composition and Diet
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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
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“ 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
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Protein-energy malnutrition impacts milk
volume. Composition remains relatively
unaffected
Water soluble vitamins move readily from
serum to milk thus dietary fluctuations are
more apparent
 B12 vegan, case report of beriberi…..
Fat soluble vitamin content not improved with
supplementation
Fatty acid composition (DHA and ARA) altered
by maternal diet and supplementation
Distribution of Kcals: Breast milk
% Protein
6
% Fat
52
% Carbohydrate
42
Protein:
Predominant protein of human milk is whey.
Casein/whey ratio is between 40:60 and
30:70
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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
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Predominant carbohydrate of breast
milk is lactose (7.3 g/dl)
Oligosaccharides (1.2 g/dl)
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Prebiotics: indigestible CHO that enhance
the growth of “favorable” bacteria and
contribute to the unique GI bacterial
characteristics of BF infant (bifidobacteria)
Fat
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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
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DHA: 0.1-1.4%
ARA: 0.31- 0.71%
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DHA lowest in populations with high meat
intake and highest in populations with high
fish intake
Breast milk and establishment
of core microbiome
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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
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Beneficial effect for the host:
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Nutrient metabolism
Tissue development
Resistance to colonization with pathogens
Maintenance of intestinal homeostasis
Immunological activation and protection of
GI integrity
Human milk and microbiome
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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
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Prebiotics
AAP Policy Statement: Breastfeeding and
the use of human milk: Pediatrics 115 #2
2005
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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:
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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
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AAP statement includes 15
recommendations on Breastfeeding
healthy term infants including:
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Establish peripartum policies and practices
supporting breastfeeding
Place infant skin to skin after delivery until
first feeding is accomplished
AAP Policy Statement:Recommendations
continued
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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
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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.
AAP Policy Statement: Breastfeeding
and the use of human milk:
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Contraindications to breastfeeding
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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
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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
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Maternal care
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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
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Infant Guidance
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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
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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.
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5 breastfed infants admitted to Children’s hospital in
Cincinnati over 5 months period for breastfeeding
malnutrition and dehydration
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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
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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
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Incidence
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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
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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
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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
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Human Milk
Human Milk
Substitutes
Science, Medicine
and Industry
Human Milk Substitutes
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Early evidence of artificial feeding
Majority of infants received breast milk
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Maternal BF
Wet nurses
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Wealthy women
Orphans, abandoned, “illegitimate”
Prematurity or congenital deformities
Wet Nurses
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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
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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
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Artificial feeding in first weeks of life
associated with 100% mortality
19th century infant mortality with “hand
feeding” was 88%
Foundlings: 80%
In Dublin Foundling hospital 1775-96:
99.6%
Science, Medicine, and
Industry
Growth of child
Health and
welfare in early
20th century
Science, Medicine, and
Industry
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Infant Morbidity and
Mortality
Recognition of
association with human
milk substitutes, and
infection
Industrial development
 Storage
 Safety
 Food industry
Historical timeline
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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
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1920
 Intro evaporated
milk
 Cod liver oil prevents
rickets
 Curd tension of milk
altered
 Increased availability
of refrigeration
 Vitamin C isolated
 Vitamin D prepared
in pure form
 Improved sanitation
Infant Formulas - History
Cow’s milk is high in protein, low in
CHO, results in large initial curd
formation in gut if not heated before
feeding
 Early Formulas
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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
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1920-1950’s: evaporated or fresh cow’s
milk, water and added CHO (prepared at
home)
1950’s to present commercially prepared
infant formulas have replaced home
recipes
Historical timeline
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1940
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Homogenized milk
widely marketed
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1960
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Further advances in
technology and
packaging
Commercially prepared
infant formula
becoming increasingly
popular
Infant Formula - History, cont.
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50s and 60s commercial formulas replaced
home preparation
1959: iron fortification introduced, but in
1971 only 25% of infants were fed Fe fortified
formula
Cow’s milk feedings started in middle of first
year between 1950-1970s. In 1970 almost
70% of infants were receiving cow’s milk.
Interesting Milestones in Infant
Nutrition
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1784: Underwood
recommends cows milk
as alternative to breast
feeding
1800: glass feeding
bottles
1838: Simon
determines protein
CM>BM
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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
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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
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Breast Milk as “gold standard”
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Attempt to duplicate composition of
breastmilk
? Bioactivity, relationship, function of all
factors present in breast milk
? Measure outcome: growth, composition,
functional indices
Formula Brands
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Ross
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Mead Johnson
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Good Start
Wyeth
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Enfamil/Prosobee/Enfacare
Nestle
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Similac/Isomil/Alimentum
Generic in USA; Gold Brands; SMA
SHS
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NeoCate, DuoCal
Distribution of Kcals
Formula
% Protein
9
% Fat
48
% Carbohydrate
42
Vitamin and Mineral content
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NAS/FDA
Meet levels at typical volumes ingested
by infants (@ 24-32 ounces)
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i.e. RDA/DRI
Standard Infant Formulas, Milk or
Soy Based………..
Cow’s Milk Based Formula
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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
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Standard 0-12 months
 Similac with iron
 Enfamil with iron
 Good Start
Essentials/Good Start
Supreme
 Wyeth Generic
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Standard 0-12 mos with
DHA/ARA
 Similac Advance with
iron
 Enfamil Lipil with
iron
 Good Start Supreme
DHA/ARA
 Wyeth formulas
Protein
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Blend of whey and
casein proteins
8.2-9.6% total calories

whey proteins of human
and cow’s milk are different
and have different amino
acid profiles.
 Major whey proteins of
human milk are
lactalbumin (high levels
of essential aa) ,
immunoglobulins, and
lactoferrin( enhances
iron transportation)
 Cow’s milk has low
levels of these proteins
and high levels of b
lactoglobulin
Cow’s Milk Based Formula: Fat & CHO
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Fat: butterfat of cow’s milk is replaced with
vegetable fat sources to make the fatty acid
profile of cow’s milk formulas more like those
of human milk and to increase the proportion
of essential fatty acids
CHO: Lactose is the major carbohydrate in
most cows’ milk based formulas.
Meets needs of healthy infants
Milk Based Pre and Probiotic
Supplemented
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Marketed to promote digestive health and
support healthy immune fx
Probiotic
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Bifidus BL
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Lactobacillus rhamosus
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Gerber Good start Protect Plus
Nutramigen Lipil with Enflora
Prebiotic
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Galactooligosaccarides (GOS)
Similac Advance Early Shield (Triple Shield),
Enfamil Premium, Generic Brands
Infant Formulas: AAP
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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
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Soy Formulas
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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
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Protein: soy protein isolate with added
methionine
Fat: vegetables oils
CHO: usually corn based products
Soy Formulas
Characteristics compared to Milk Based
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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.
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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
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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
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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.
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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
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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)
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“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
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Alimentum Advance
Pregestimil/Pregestimil Lipil
Nutramigen Lipil
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Protein Casein hyrolysate + free AA’s
Fat (Alimentum and Pregestimil)
Medium chain + Long chain
triglycerides;
(Nutramigen) Long
chain triglycerides
Hydrolysate Formulas
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Whey Hydrolysate Formula: Cow’s milk based
formula in which the protein is provided as whey
proteins that have been hydrolyzed to smaller protein
fractions, primarily peptides. This formula may
provoke an allergic response in infants with cow’s
milk protein allergy.
Casein Hydrolysate Formula: Infant formula
based on hydrolyzed casein protein, produced by
partially breaking down the casein into smaller
peptide fragments and amino acids. `
Cow’s milk protein avoidance and development of
childhood wheeze in children with a family history of
atopy
(Cochrane, 2003)
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Breast-milk should remain the feed of choice
for all babies.
In infants with at least one first degree
relative with atopy, hydrolysed formula for a
minimum of four months combined with
dietary restrictions and environment
measures may reduce the risk of developing
asthma or wheeze in the first year of life.
There is insufficient evidence to suggest that
soya-based milk formula has any benefit.
Formulas containing hydrolysed protein
for prevention of allergy and food
intolerance in infants (2006)

There is no evidence to support feeding with a
hydrolysed formula for the prevention of allergy
compared to exclusive breast feeding. In high risk
infants who are unable to be completely breast fed,
there is limited evidence that prolonged feeding with
a hydrolysed formula compared to a cow's milk
formula reduces infant and childhood allergy and
infant cow’s milk allergy. In view of methodological
concerns and inconsistency of findings, further large,
well designed trials comparing formulas containing
partially hydrolysed whey, or extensively hydrolysed
casein to cow's milk formulas are needed.
AAP Policy Statement Re: Hypoallergenic
Infant Formulas (August, 2000)
Recommendations
AAP Policy Statement Re: Hypoallergenic
Infant Formulas (August, 2000)

Currently available, partially hydrolyzed
formulas are not hypoallergenic.
2.Formula-fed infants with confirmed
cow's milk allergy may benefit from the
use of a hypoallergenic or soy formula
as described for the breastfed infant.
3.Infants at high risk for developing allergy,
identified by a strong (biparental; parent, and
sibling) family history of allergy may benefit
from exclusive breastfeeding or a
hypoallergenic formula or possibly a partial
hydrolysate formula. Conclusive studies are
not yet available to permit definitive
recommendations. However, the following
recommendations seem reasonable at this
time:
AAP Policy Statement Re: Hypoallergenic
Infant Formulas (August, 2000)

Carefully conducted randomized controlled
studies in infants from families with a history
of allergy must be performed to support a
formula claim for allergy prevention. Allergic
responses must be established prospectively,
evaluated with validated scoring systems, and
confirmed by double-blind,placebo-controlled
challenge. These studies should continue for
at least 18 months and preferably for 60 to
72 months or longer where possible
Elemental formula for
infants
Amino Acid Based Formulas

Elecare, Neocate, Nutramigen AA


Protein: Free Amino Acids
Fat: Long chain and medium chain



Elecare (33% MCT), Neocate (5% MCT)
Carbohydrate: corn syrup solids,
Lactose and sucrose free
Indications for use: Food Allergy or
intolerance to peptides or whole
protein
Elemental Infant Formula

NeoCate (SHS)
Protein: Free Amino Acids
 Fat: Long chain
 Carbohydrate: Lactose Free
 Indications for use: Food Allergy
or intolerance to peptides or
whole protein

Other Specialty Formulas

Portagen



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 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
Premature Formula
Protein: Whey
Predominant
Standard Infant
Formula
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

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
Know What You Are Feeding
n
n
n
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.
n
Evidence Based
n
Rationale
n
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. DRI’s)
 Guidelines for preparation and handling of
formula/human milk in health care facilities
Regulation of Infant Formulas

Infant Formula Act:


Manufacturing regulations
Quality control




Non specific testing requirements, case by case basis,
growth outcomes
Recall Proceedures
Nutrient content and labeling
Panel convened 1998 and 2002 (recommended
revisions including exemptions)
Regulation of Infant Formulas

Infant Formula Act: The purpose of the infant
formula act (1980) is to ensure the safety and
nutrition of infant formulas – including minimum and
in some cases maximum levels of specified nutrients.
The act authorizes the FDA to establish appropriate
regulations for 1) new formulas, 2) formulas entering
the U.S. market, 3) major changes, revisions, or
substitutions of macronutrients 4) formulas
manufactured in new plants or processing lines, 5)
addition of new constituents 6) use of new
equipment or technology 7) packaging changes
Formula Regulation



Regulation is by the Infant Formula Act of
1980, under FDA authority
Nutrient composition guidelines for 29
nutrients established by AAP Committee on
Nutrition and adopted as regs by FDA
Nutrient Requirements for Infant Formulas.
Federal Register 36, 23553-23556. 1985. 21
CFR Part 107.
Infant Formula Act


Institute of Medicine Food and Nutrition Board
3/2004
“Although the federal regulatory processes for
evaluating the safety of food ingredients have
worked well for conventional substances, they
were not designed to ensure the needs and
vulnerabilities of infants and are insufficient to
ensure the safety of new types of ingredients
proposed for infant formulas
Infant Formula Act

“The current regulatory processed do not fully
address the unique role of formula as a food
source. Formula is the only infants’ food if they are
not being breastfed. The processes used to
regulate the safety of any new additions of formula
should be tailored to these products distict role and
the special needs and susceptibilities of infants”
Infant Formula Act


Key limitation: lack of explicit
guideleines for determining when and
what safety data is needed…..(GRAS)
Clarification is crucial given the
increasing number of bioactive peptides
and enzymens generated from
unconventional sources or new
technologies
Infant Formula Act: Points for
discussion


Addition of DHA and ARA to formulas
Addition of prebiotics to formula




Present in BM
GRAS
Vitamin/mineral content conforms to
regulation
? testing
Formula Safety Issues - 2002




Enterobacter Sakazakii in Intensive care units
Powered formula is not sterile so should not
be used with high risk infants
FDA recommends mixing with boiling water
but this may affect availability of vitamins &
proteins and also cause clumping
Irradiation proposed
Formula safety

FDA recall list 2005-2006
Formula Safety

Infant Feedings: Guidelines for
Preparation of Formula and
Breastmilk in Health Care Facilities:
Pediatric Nutrition Practice Group
of ADA 2003






AAP
AHA
ANA
FDA
CDC
others
Milk Feedings
Cautionary Tales


Keating et al. AJDC 1991. Oral water
intoxication in infants.
Lucas et al. Arch Dis Child. 1992.
Randomized trial of ready to fed
compared with powdered formula.
Keating



24 cases of oral water intoxication in 3 years
at Children’s Hospital and St. Louis
Most were from very low income families and
were offered water at home when formula
ran out
Authors suggest: provision of adequate
formula and anticipatory guidance
Lucas




43 infants randomized to RTF or powdered formula
Infants given powdered formula had increased body
wt. And skinfold thickness at 3 and 6 mos..
Compared to RTF and breastfed
Powdered formula - 6 of 19 were above the 90th
percentile wt/ht, but only 1 of 19 RTF infants
Authors suggest errors in reconstitution of formula
Formula Safety


Iron and Breastmilk
Powdered products in at-risk
populations


Non sterile
Recommend against use unless no other
alternative
Bright Futures



AAP/HRSA/MCHB
http://www.brightfutures.org
“Bright Futures is a practical
development approach to providing
health supervision for children of all
ages from birth through adolescence.”
Additional concerns/issues

Appropriate infant feeding




Cows milk, goats milk, homemade formulas
safety
Preparation: mixing, storing, warming
(microwave)
miscellaneous
Formula Safety





Separate room for mixing
Aseptic conditions
Gram scale, appropriately calibrated
measuring tools
Standardized recipes
Temperature, hang time etc
Cows milk and goats milk




Protein
RSL
Folic acid, iron, vitamin D
pasteurization
AAP: Cow’s Milk in Infancy

Objections include:
Cow’s milk poor source of iron
 GI blood loss may continue past 6 months
 Bovine milk protein and Ca inhibit Fe
absorption
 Increased risk of hypernatremic
dehydration with illness
 Limited essential fatty acids, vitamin C, zinc
 Excessive protein intake with low fat milks

Newborn Visit: Bottle-feeding




type of formula, preparation
feeding techniques, and equipment.
Hold baby in semi-sitting position to feed.
Do not use a microwave oven to heat
formula.
To avoid developing a habit that will harm
your infant's teeth, do not put him to bed
with a bottle or prop it in his mouth.