1. Continuity Clinic Infant Formulas

2. Continuity Clinic

3. Objectives Know the history and regulation of infant formulas Categorize formulas by composition and intended use Know what alternate products to give to infants with specialized problems

4. Continuity Clinic Infant Formula Product intended for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk

5. Continuity Clinic Highlights in Formula History 1929--the first soy flour formula was developed –milk–free, lactose–free –designed as an alternative to the home prepared milk–based formulas of the time –soy flour caused significant abd discomfort 1942--protein hydrolysate formula 1959—iron-fortified formula appeared 1960—appreciation of renal solute load 1965--soy protein isolate formula

6. Continuity Clinic 1966—1 st premmie formula designed to meet the special nutritional needs of rapidly growing low–birth–weight infants. 1971--first nutritionally complete protein hydrolysate formula containing MCT oil. 1990’s –lactose free cow milk-based formulas appeared –Nucleotides were added to some formulas Early 2000’s –DHA & ARA added to milk and soy formula Highlights in Formula History

7. Continuity Clinic Regulation of Infant Formulas The US was one of the last major industrialized nation to implement federal regulations concerning safety of infant formulas The first FDA reference to safety of infant formulas was in 1938 1941 first requirement for specific information to be included on an infant formula label No new revisions until 1971 when the results of AAP recommendations and public hearings included minimum requirements for protein, fat, linoleic acid and 17 vitamins and minerals.

8. Continuity Clinic Infant Formula Act Passed by Congress in 1980 Following reports in 1979 that over 100 infants became seriously ill because of the lack of chloride in two soy-based formulas The new law authorized the FDA to adjust nutritional standards for infant foods to conform with the best available scientific knowledge. Manufacturers are required to test their products periodically and report to the FDA when they do not meet the official specs.

9. Continuity Clinic Furthermore….Formula Manufacturers are required to Verify composition before a new product goes to market –specifying that it meets minimum (29 nutrients) and does not exceed maximum (9 nutrients) requirements Meet “good manufacturing practices” Maintain records for annual inspection The FDA has the authority to recall products that are adulterated or misbranded

10. Continuity Clinic Categories of Infant formulas Standard –Similac, Enfamil, Carnation, Store brands Soy –Isomil, Prosobee, Alsoy, Protein hydrolysates –Pregestimil, Nutramigen, Alimentum Elemental –Neocate, Elecare Premature –Enfacare, NeoSure “Next Step”—older infants and toddlers Specialized –Modified for specific medical indication Metabolic, renal, GI disorders

11. Continuity Clinic Standard Formulas Cow milk altered by –Removing the butter fat –Adding vegetable oils and carbohydrate –Decreasing the protein 34 g/L to  15 g/L –Adding vitamins, minerals, and other nutrients such as amino acids, fatty acids, nucleotides Whey to casein ratio varies –Major whey protein is β-lactoglobulin –Major casein protein is bovine  -casein –Amino acid profile varies –Taurine and carnitine are added to some

12. Continuity Clinic Whey to Casein Ratio % Whey% Casein Breast milk70  -lactalbumin, lactoferrin, IgA 30 β-casein Enfamil6040 Similac1882 Carnation Good Start 1000 Soy00

13. Continuity Clinic Standard Formula Features Breast milk –20cal/oz –Human milk fat –Lactose –whey:casein 70:30 9 g/L –Iron 0.3mg/L –Vitamin D 21 IU/L –260 mOsm/kg H 2 0 –Contains DHA and AA Enfamil/Similac/Good Start –20cal/oz –Soy, coconut, sunflower, palm –Lactose –60:40, 18:82  15 g/L –Iron 12mg/L –Vitamin D 405 IU/L –265-300 mOsm/kg H 2 0 –DHA and AA added Formulas still made without

14. Continuity Clinic Standard Formula Features Breast milk –20cal/oz –Human milk fat –Lactose –whey:casein 70:30 9 g/L –Iron 0.3mg/L –Vitamin D 21 IU/L –260 mOsm/kg H 2 0 –Contains DHA and AA Enfamil/Similac/Good Start –20cal/oz –Soy, coconut, sunflower, palm –Lactose –60:40, 18:82  15 g/L –Iron 12mg/L –Vitamin D 405 IU/L –300 mOsm/kg H 2 0 –DHA and AA added Formulas still made without

15. Continuity Clinic Low Iron Formula “ The manufacture of formulas with iron concentrations less than 4.0 mg/L should be discontinued. If these formulas continue to be made, low-iron formulas should be prominently labeled as potentially nutritionally inadequate with a warning specifying the risk of iron deficiency. These formulas should not be used to treat colic, constipation, cramps, or gastroesophageal reflux.” PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123 AMERICAN ACADEMY OF PEDIATRICS: Iron Fortification of Infant Formulas Position Statement

16. Continuity Clinic Soy Formulas Indications for use –Milk protein intolerance (IGE mediated) –Lactose intolerance (rare) –Galactosemia –Vegetarian diet Not appropriate for –preterm infants < 1800 grams d/t risk of osteopenia and growth concerns –Hereditary fructose intolerance (contains sucrose)

17. Continuity Clinic Soy Formulas Breast milk –20cal/oz –Human milk fat –Lactose –whey:casein 70:30 9 g/L –Iron 0.3mg/L –Vitamin D 21IU/L –260 mOsm/kg H 2 0 –Contains DHA and AA Isomil/Prosobee –20cal/oz –palm olein, soy,coconut,sunflower –Corn syrup/sucrose –Protein, 17 g/L soy isolate and L-MET –Iron 12mg/L –Vitamin D 405 IU/L –200 mOsm/kg H 2 0 –DHA and AA added

18. Continuity Clinic Protein Hydrolysates Hydrolyzed casein or whey protein Various fat blends All are lactose free

19. Continuity Clinic Protein Hydrolysates Breast milk –20cal/oz –Human milk fat –Lactose –70%whey 30%casein 9 g/L –Iron 0.3mg/L –Vit D 21 IU/L –260 mOsm/kg H 2 0 –Contains DHA and AA Pregestimil –20cal/oz –MCT (55%), safflower, soy –corn syrup solids, corn starch –Casein Hydrolysate- nonantigenic peptides 19 g/L –Iron 12mg/L –Vitamin D 405 IU/L –330 mOms/kg H 2 0 –Does not have DHA and AA

20. Continuity Clinic Other Hydrolysates Alimentum Advance –For infants and children with severe food allergies, sensitivity to intact protein (including colic symptoms due to protein sensitivity), protein maldigestion or fat malabsorption –Hydrolyzed casein + free amino acids –33% of fat is MCT –370 mOms/kg H 2 0 –Contains DHA and ARA –Lactose free (contains sucrose) Nutramigen LIPIL –hypoallergenic –for infants who are sensitive to intact protein in milk and soy-based formulas –270 mOms/kg H 2 0 –Lactose and sucrose free

21. Continuity Clinic New Kid on the Block!

22. Continuity Clinic Enfamil Gentlease LIPIL –Launched in July 05 –“is a nutritionally balanced, milk-based infant formula designed as a first switch formula for babies who have fussiness or gas.” –Partially broken down proteins 6-9% hydrolyzed –Reduced lactose 1/4 of typical –Whey:casein ratio of 60:40 –Contains DHA and ARA, “nutrients also found in breast milk that promote brain and eye development.” –No studies to document efficacy in the intended population

23. Continuity Clinic Elemental Formulas Indications: For infants and children who need an amino acid-based medical food or who cannot tolerate intact protein –protein maldigestion or malabsorption Short bowel syndrome –severe or multiple food allergies –GI tract impairment eosinophilic esophagitis or gastroenteritis –Lactose, sucrose, fructose, and galactose- free Galactosemia and hereditary fructose intolerance

24. Continuity Clinic Elemental Breast milk –20cal/oz –Human milk fat –Lactose –70%whey 30%casein 9 g/L –Iron 0.3mg/L –Vit D 21 IU/L –260 mOsm/kg H 2 0 –Contains DHA and AA Neocate/Elecare –20cal/oz –MCT, safflower, soy –Corn syrup solids –100% free amino acids, 21 g/L –Iron 12mg/L –Vitamin D 500 IU/L –335 mOsm/kg H 2 0 –Do not contain DHA and AA 5% MCT 33% MCT

25. Continuity Clinic Premature Formulas NICU –Similac Special Care Enfamil Premature Lipil 20 and 24 kcal/oz Available only for inpatients Cow milk based 40% of fat is MCT Not appropriate for larger babies (2.5-3 kg) because of increased vitamins(ie A and D) and minerals

26. Continuity Clinic Premature Infants Hospital discharge –NeoSure –EnfaCare 22 kcal/oz  Pro, calcium, phosphorus, MCT (20%) Cow milk based Improved growth –Wheeler, RE. Journal of Perinatology, 16:111-116, 1996.

27. Continuity Clinic Preemie Post Discharge Use until 9-12 months or Baby has achieved “catch-up” growth Normal dilution is 22 calorie per ounce Higher protein, minerals Supports growth & bone mineralization Cow’s milk base Enfacare Lipil and Similac Neosure Advance

28. Continuity Clinic Others Enfamil AR –Milk-based standard formula –added rice starch that thickens in the acid environment of the stomach –For babies who spit up frequently or need a thickened formula –Reduced reflux symptoms Vanderhoof, Clin Pediatr. 2003;42:483-495. Isomil DF –Soy protein, soy fiber –For firming loose, watery stools in infants older than 6 months and toddlers. –  duration of antibiotic-induced diarrhea Burks, J Pediatr. 2001;139(4):578

29. Continuity Clinic Others Enfamil LactoFree –Milk-based –Lactose and sucrose-free formula for infants with fussiness, gas or diarrhea due to lactose sensitivity. –Calcium absorption was less than with lactose containing formula but total calcium absorption was adequate (Abrams, AJCN;2002) –Studies on efficacy have been mixed

30. Continuity Clinic Generic Formulas Must meet requirements set under the infant formula act –Minimums and maximums Less expensive

31. Continuity Clinic Specialized, cont: Similac PM 60/40 –For infants with hypocalcemia due to hyperphosphatemia or impaired renal function. Metabolic Formulas –PKU, MSUD, tyrosinemia, homocystinuria, glutaric aciduria, PPA/MMA, urea cycle –Ross, Mead Johnson, Scientific Hospital Supplies

32. Continuity Clinic Toddler Formulas Milk and soy based products for infants and toddlers –9-24 months –who are eating solid foods Contain DHA and ARA Has > twice the calcium of regular infant formulas (300 mg vs 125 mg)

33. Continuity Clinic

34. Choose the appropriate formula: Infant with galactosemia –Isomil, Prosobee, Pregestimil, Neocate, Elecare Infant with multiple food allergies –Hydrolysate then Neocate, Elecare Healthy term infant –Enfamil or Similac Infant with decreased pancreatic lipase and bile salts –Portagen Infant with  renal fx and  electrolytes –Similac PM 60/40

35. Continuity Clinic Nipples, Bottles, Feeding….Oh My! Nipples –Material Rubber (disposable after one use) Plastic Silicone –Hole Size  1 through 3 –Shapes  ie Nuk –Specialized for things like cleft palate, prematures

36. Continuity Clinic Cleft Palate Haberman feeder – adjustable slit valve in nipple to control flow; has a reservior Mead Johnson – soft squeezable bottle Pigeon nurser – nipple firm on one side to provide support; also flow regulator Keys to feeding: burp often, feed upright, cheek support, may need to spoon feed