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

2. “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

3. Characteristics and Advantages of Human Milk Low renal solute load Immunologic, growth and trophic factors Decrease illness, infection, allergy Improved digestion and absorbtion Nutrient Composition: CHO, Protein, Fatty Acid, etc Cost Other

4. Infant Feeding: Historical Perspective Breast feeding Human Milk Substitutes Science, Medicine and Industry

5. Human Milk Substitutes Wet nurses Other mammalian milk (cow, goat, donkey, camel) Pablum: bread/flour, mixed with water “bread, water, flour, sugar and castille soap to aid digestion”

6. Human Milk Substitutes 1915 Gerstenberger developed first “complete infant formula” marketed as SMA (synthetic milk adapted) Base was defatted and diluted cow’s milk with beef tallow added to mimic the fat content of human milk

7. Human Milk Substitutes 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

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

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

10. 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

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

12. 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

13. 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

14. 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)

15. 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

16. Approaches to Estimating Nutrient Requirements Direct experimental evidence ie protein and amino acids extrapolation from experimental evidence relating to human subjects of other age groups or animal models ie thiamin--related to energy intake.3-.5 mg/1000 kcal Breast milk as gold standard ie average [ ] X usual intake Metabolic balance studies ie protein, Ca, Mg, Cu, Zn (may be overestimate) Clinical Observation ie formula manufacturing errors B6, Cl Factorial approach

17. 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

18. Feeding the Infant Considerations Infant (needs, tolerance, acceptance, safety) Indications Family preferences Cost availability

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

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

21. 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

22. Milk Based Formulas Characteristics Blend of Whey and Casein Proteins (8.2-9.6 % total calories) Carbohydrate: lactose Fats: long chain Meet needs of healthy infant

23. 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

24. 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

25. Predigested protein based infant formulas

26. 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

27. Elemental formula for infants

28. 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

29. 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

30. Premature Formulas General Characteristics compared to Standard Increased Protein,Vitamins & Minerals For infants born at <1.5kg up to 2000-2500gm Feeding of infants > 2500 gm risk of vitamin toxicities Premature formulas vary in nutrient content

31. Post Premature Infant formula

32. “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

33. 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

34. Indications Cow’s milk based 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

35. Modification of Infant Formulas Cost and Availability Potential mixing errors Impact on absorbtion, utilization and interaction of nutrients Evidence Based Requires detailed assessment to determine need

36. Modular Products to Increase Energy/Protein

37. Modular Products to increase Energy or Protein

38. Products to Augment Energy and Protein in Breast Milk Human Milk Fortifiers For Premature infants less than 2000- 2500gm only Standard Infant Formula Powder * 1 teaspoon to 100mL = 24kcal/oz+/- Do Not Add CHO or Fat w/o protein : Final product is TOO LOW in protein

39. Finding Up to Date Information www.ross.com Similac products www.ross.com www.meadjohnson.com Enfamil products www.meadjohnson.com www.verybestbaby.com Nestle products www.verybestbaby.com www.wyethnutritionals.com generic products www.wyethnutritionals.com www.brightbeginnings.com lower cost formulas made by Wyeth www.shsna.com/html/Hypoallergenic.htm Neocate formulas

41. When Baby is Not Growing Normal Weight gain and linear growth Evaluate growth rates (weight, length, OFC) in addition to absolute size (percentiles), body composition, weight/length Guo et al J Pediatrics 1991

42. When Baby is Not Growing Assess Feeding Number feedings/day Feeding environment BF: baby “empties” breasts each feeding Formula: volume per feeding Feeding observation

43. When Baby is Not Growing Medical status, illness, vomiting, output Development and behavior Psychosocial Diet Frequency Amount Preparation content

44. When Baby is not growing Identify Problem Address Problem Formula Changes or modifications Risk vs benefit Cost Availability Addresses problem

45. Know What You Are Feeding n Caloric density, protein, fat and carbohydrate vitamin and mineral content. n Osmolality: n Renal Solute Load: Evaluate RSL in context of solute intake, fluid intake and output. n Evidence Based n Rationale n Cost and availability