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

2. Infant Feeding: Historical Perspective
Human Milk
Human Milk Substitutes
Science, Medicine and Industry

3. Feeding the Infant Considerations
Infant (needs, tolerance, acceptance, safety)
Family preferences
Cost and availability
Prevention, health, development, and programming

4. 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

5. Human Milk

6. “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

7. Human Milk Complements infant Immaturity Promotes maturation
Epithelial growth factors and hormones
Digestive enzymes - lipases and amylase 7

8. 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

9. Human Milk Colostrum Higher concentration of protein and antibodies
Transitions around days 3-5
Mature by day 10

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.

11. 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”

12. 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

13. 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

14. How is milk made?

15. 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

16. 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

17. 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.

18. 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

19. 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

20. 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,…..

21. 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

22. 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”

23. 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

24. Distribution of Kcals: Breast milk24

25. 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 25

26. 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)

27. 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

28. DHA/ARA concentration variation in human milk
DHA lowest in populations with high meat intake and highest in populations with high fish intake

29. 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

30. 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

31. 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

32. 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)

33. 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.

34. 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

35. 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

36. 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. 36

37. 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)

38. 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.”

39. 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.

40. 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.

41. Cautionary Tales
Cooper et al. Pediatrics Increased incidence of severe breastfeeding malnutrition and hypernatremia in a metropolitan area.
Rolf et al. ACTA Paediatrica 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 41

42. Cooper.
5 breastfed infants admitted to Children’s 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 ( 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 42

43. Rolf
Survey to determine incidence and characteristics of hospital admission due to dehydration
Dutch Paediatric Surveillance Unit 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

44. Rolf Incidence Characteristics in infants < 11 days
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:
Other characteristics: lethargy, jaundice, shock/seizures, evidence of inadequate intake via pre/post weights (67%)

45. 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….

46. Infant Feeding: Historical Perspective
Human Milk
Human Milk Substitutes
Science, Medicine and Industry

47. 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

48. 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

49. 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

50. 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 : 99.6%

51. Science, Medicine, and Industry
Growth of child Health and welfare in early 20th century

52. Science, Medicine, and Industry
Infant Morbidity and Mortality
Recognition of association with human milk substitutes, and infection
Industrial development
Storage
Safety
Food industry

53. Historical timeline 1900 Pasteurization of milk in US
Association between bacteria and diarrhea
1912
U.S Children’s Bureau
Public Health and Pediatricians efforts to improve infant/child health and decrease mortality
1920
Intro evaporated milk
Cod liver oil prevents rickets
Curd tension of milk altered
Increased availability of refrigeration
Vitamin C isolated
Vitamin D prepared in pure form
Improved sanitation

54. Infant Formulas - History
Cow’s milk is high in protein, low in CHO, results in large initial curd formation in gut if not heated before feeding
Early Formulas
from 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 54

55. Human Milk Substitutes
’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

56. Historical timeline 1940 1960 Homogenized milk widely marketed
Further advances in technology and packaging
Commercially prepared infant formula becoming increasingly popular

57. Infant Formula - History, cont.
50s and 60s commercial formulas replaced home preparation
1959: iron fortification introduced, but in 1971 only 25% of infants were fed Fe fortified formula
Cow’s milk feedings started in middle of first year between s. In 1970 almost 70% of infants were receiving cow’s milk. 57

58. 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

59. Interesting Milestones in Infant Nutrition
1911: MJ introduces Dextri-maltose
1915: SMA
1920: Franklyn (Similac)
1929: MJ markets Sobee, hypoallergenic
: Concentrated liquid, hydrolysed, elemental, and ready to feed formulas introduced
What now?

60. Formula

61. 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

62. Formula Brands Ross Mead Johnson Nestle Wyeth SHS
Similac/Isomil/Alimentum
Mead Johnson
Enfamil/Prosobee/Enfacare
Nestle
Good Start
Wyeth
Generic in USA; Gold Brands; SMA
SHS
NeoCate, DuoCal

63. Distribution of Kcals 63

64. Vitamin and Mineral content
NAS/FDA
Meet levels at typical volumes ingested by infants ounces)
i.e. RDA/DRI

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

66. Cow’s 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 66

67. 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

68. Protein 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 68

69. Cow’s Milk Based Formula: Fat & CHO
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 69

70. Milk Based Pre and Probiotic Supplemented
Marketed to promote digestive health and support healthy immune fx
Probiotic
Bifidus BL
Gerber Good start Protect Plus
Lactobacillus rhamosus
Nutramigen Lipil with Enflora
Prebiotic
Galactooligosaccarides (GOS)
Similac Advance Early Shield (Triple Shield), Enfamil Premium, Generic Brands

71. Infant Formulas: AAP
Cow’s milk based formula is recommended for the first 12 months if breast milk is not available 71

72. Soy Formulas First developed in 1930s with soy flour
Early formulas produced diarrhea and excessive gas
Now use soy protein isolate with added methionine 72

73. 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

74. Soy Formulas Protein: soy protein isolate with added methionine
Fat: vegetables oils
CHO: usually corn based products 74

75. 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

76. Soy formulas given to 25% of infants but needed by very few
American Academy of Pediatrics Committee on Nutrition. Soy Protein-based Formulas: Recommendations for Use in Infant Feeding. Pediatrics 1998;101:
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 76

77. 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 77

78. Health Consequences of Early Soy Consumption. Badger et al. J Nutr
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. 78

79. 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). 79

80. 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 80

81. 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. 81

82. 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.”

83. Predigested protein based infant formulas

84. Protein Hydrolysate Formulas
Alimentum Advance
Pregestimil/Pregestimil Lipil
Nutramigen Lipil
Protein Casein hyrolysate + free AA’s
Fat (Alimentum and Pregestimil) Medium chain + Long chain triglycerides; (Nutramigen) Long chain triglycerides
Carbohydrate: Lactose free

85. Hydrolysate Formulas
Whey Hydrolysate Formula: Cow’s milk based formula in which the protein is provided as whey proteins that have been hydrolyzed to smaller protein fractions, primarily peptides. This formula may provoke an allergic response in infants with cow’s milk protein allergy.
Casein Hydrolysate Formula: Infant formula based on hydrolyzed casein protein, produced by partially breaking down the casein into smaller peptide fragments and amino acids. ` 85

86. Breast-milk should remain the feed of choice for all babies.
Cow’s 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.

87. 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.

88. AAP Policy Statement Re: Hypoallergenic Infant Formulas (August, 2000)
Recommendations 88

89. AAP Policy Statement Re: Hypoallergenic Infant Formulas (August, 2000)
Currently available, partially hydrolyzed formulas are not hypoallergenic. 89

90. 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. 90

91. 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: 91

92. 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 92

93. Elemental formula for infants

94. 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

95. 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

96. Other Specialty Formulas
Portagen (Mead Johnson)
85% fat MCT, 15% fat Corn oil
Used for infants with chylothorax
Similac PM 60/40 (Ross)
Low in Ca, P, K+ and NA; 2:1 Ca:P ratio
Used for infants with Renal Failure
Formulas for Metabolic Disorders
Several condition specific products by Ross and Mead Johnson

97. Premature Formulas General Characteristics compared to Standard
Increased Protein,Vitamins & Minerals
For infants born at <1.5kg
up to gm
Feeding of infants > 2500 gm
risk of vitamin toxicities
Premature formulas vary in nutrient content

98. 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 oz
Iso-osmolar

99. 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

100. Post Premature Infant formula

101. “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

102. Formulas with DHA & ARA
102

103. Indications Cow’s milk based Soy Protein Hydrolysates Preterm Formulas
Health term infant
Soy
Vegetarian
Galactosemia
Protein Hydrolysates
Protein intolerance/allergy
other
Preterm Formulas
Post-discharge Preterm formulas
Other Specialty Formulas
Specific medical, metabolic indications

104. 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

105. Finding Up to Date Information
Similac products
Enfamil products
Nestle products
generic products
lower cost formulas made by Wyeth
Neocate formulas

106. 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

107. 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)

108. 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

109. 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, CFR Part 107.
109

110. 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

111. 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”

112. 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

113. 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

114. 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
114

115. Formula safety
FDA recall list

116. 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

117. Milk Feedings Cautionary Tales
Keating et al. AJDC Oral water intoxication in infants.
Lucas et al. Arch Dis Child Randomized trial of ready to fed compared with powdered formula.
117

118. 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

119. 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

120. Formula Safety Iron and Breastmilk
Powdered products in at-risk populations
Non sterile
Recommend against use unless no other alternative

121. 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.”

122. Additional concerns/issues
Appropriate infant feeding
Cows milk, goats milk, homemade formulas
safety
Preparation: mixing, storing, warming (microwave)
miscellaneous

123. Formula Safety Separate room for mixing Aseptic conditions
Gram scale, appropriately calibrated measuring tools
Standardized recipes
Temperature, hang time etc

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

125. 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
125

126. 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.