Infant Formulas_Camp

Infant Formulas_Camp - Infant Formulas Infant What’s for...

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Unformatted text preview: Infant Formulas Infant What’s for What and What’s for What’s Whom??? Whom??? Kathryn Camp, MS, RD, CSP Pediatric Nutritionist Walter Reed Army Medical Center Today’s Presentation Today’s History and regulation of infant History formulas formulas Categorize formulas by Categorize composition and intended use composition Alternate products sometimes given Alternate to infants to Infant Formula Infant Product intended for use by infants that Product simulates human milk or is suitable as a complete or partial substitute for human milk milk Historical Perspective Historical Early attempts at artificial feeding of infants Early employed the milk of other mammals employed – Infant survival during the 1st few weeks of life approached 0% approached Wet nurses were employed but their Wet availability declined with the onset of the Industrial Revolution Examples of Early Infant Feeding Vessels Vessels Pewter Ceramic Commercial Formula Development Development In 1867, Henri In Nestlé created the first commercially sold formula. sold Banana feeder At the end of the 19th century the gross At composition of human milk was determined. Recognition of low concentration of protein in BM lead to the use of diluted cow milk in – Less mortality among infants – But poor growth To increase caloric density of diluted cow To milk, sugar or cereals were added milk, – Infants lived and grew – Pediatrics became a medical specialty – Mortality still remained high Mortality Early 20th century Early – Electric refrigeration and pasteurization Significant decrease in mortality Increased popularity of formula feeding – Improved sanitation and milk handling – Modifications in cow protein improved Modifications digestibility digestibility – Direct advertising to physicians Direct influenced use of formulas influenced – Good rubber nipples made feeding Good easier easier 1911-- Dextri-Maltose introduced by Mead Johnson Mead 1915 -- a formula called synthetic 1915 milk adapted (forerunner of Wyeth’s SMA) required only the addition of water water – 67 kcal/dL – Non-fat cow milk – Lactose – Oleo and vegetable fat The importance of vitamins was recognized recognized – Infant formulas became suitable vehicles – Previously common vitamin-deficiency Previously diseases such as scurvy and rickets became less prevalent less Highlights in Formula History Highlights 1929--the first soy flour formula was 1929--the developed developed – milk–free, lactose–free milk–free, – designed as an alternative to the home designed prepared milk–based formulas of the time prepared – soy flour caused significant abd discomfort soy 1942--protein hydrolysate formula 1942--protein 1959—iron-fortified formula appeared 1959—iron-fortified 1960—appreciation of renal solute load 1965--soy protein isolate formula 1965--soy 1966—1st premmie formula designed to 1966—1 meet the special nutritional needs of rapidly growing low–birth–weight infants. 1971--first nutritionally complete protein hydrolysate formula containing MCT oil. 1990’s 1990’s – llactose free cow milk-based formulas actose appeared appeared – Nucleotides were added to some formulas Early 2000’s – DHA and ARA were added to both cow milk DHA and soy formulas and Regulation of Infant Formulas Regulation The US was one of the last major industrialized The nation to implement federal regulations concerning safety of infant formulas concerning The first FDA reference to safety of infant The formulas was in 1938 formulas 1941 first requirement for specific information to 1941 be included on an infant formula label be No new revisions until 1971 when the results of No AAP recommendations and public hearings included minimum requirements for protein, fat, linoleic acid and 17 vitamins and minerals. linoleic Infant Formula Act Passed by Congress in 1980 Congress Following reports in 1979 that over 100 infants Following became seriously ill because of the lack of chloride in two soy-based formulas chloride The new law authorized the FDA to adjust The 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. when Furthermore….Formula Manufacturers are required to Manufacturers Verify composition before a new product Verify goes to market – specifying that it meets minimum (29 specifying nutrients) and does not exceed maximum (9 nutrients) requirements nutrients) Meet “good manufacturing practices” Maintain records for annual inspection The FDA has the authority to recall The products that are adulterated or misbranded misbranded Categories of Infant formulas Categories Standard – Similac, Enfamil, Carnation, Store brands Similac, Soy Soy – Isomil, Prosobee, Alsoy, Isomil, Protein hydrolysates Protein – 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 Standard Formulas Standard Cow milk altered by Cow – Removing the butter fat – Adding vegetable oils and carbohydrate – Decreasing the protein 34 g/L to ≥ 15 g/L 34 – Adding vitamins, minerals, and other nutrients such Adding as amino acids, fatty acids, nucleotides as Whey to casein ratio varies – – – – Major whey protein is β-lactoglobulin Major Major casein protein is bovine α-casein Major Amino acid profile varies Taurine and carnitine are added to some Whey to Casein Ratio Whey % Whey Breast milk % Casein 70 70 30 30 β-casein α-lactalbumin, -lactalbumin, lactoferrin, IgA lactoferrin, Enfamil 60 40 Similac 18 82 Carnation Carnation Good Start Good 100 0 Soy 0 0 Standard Formula Formula Features Breast milk Enfamil/Similac/Good Start – – – – 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 H20 – – – – – Contains DHA and AA – DHA and AA added DHA 20cal/oz Soy, coconut, sunflower, palm Soy, Lactose 60:40, 18:82 60:40, ≥ 15 g/L 15 – Iron 12mg/L – Vitamin D 405 IU/L – 265-300 mOsm/kg H20 Formulas still made without Formulas Standard Formula Formula Features Breast milk Enfamil/Similac/Good Start – – – – 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 H20 – – – – – Contains DHA and AA – DHA and AA added DHA 20cal/oz Soy, coconut, sunflower, palm Soy, Lactose 60:40, 18:82 ≥ 15 g/L – Iron 12mg/L – Vitamin D 405 IU/L – 300 mOsm/kg H20 Formulas still made without Formulas Low Iron Formula Low PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123 AMERICAN ACADEMY OF PEDIATRICS: Iron Fortification of Infant Formulas Position Statement “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.” Soy Formulas Soy Indications for use – Milk protein intolerance (IGE mediated) – Lactose intolerance (rare) – Galactosemia – Vegetarian diet Not appropriate for Not – preterm infants < 1800 grams d/t risk of preterm osteopenia and growth concerns osteopenia – Hereditary fructose intolerance (contains Hereditary sucrose) sucrose) Soy Formulas Soy 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 H20 Contains DHA and Contains AA AA Isomil/Prosobee – 20cal/oz – palm olein, palm soy,coconut,sunflower 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 H20 – DHA and AA added Protein Hydrolysates Protein Hydrolyzed casein or whey protein Various fat blends All are lactose free Protein Hydrolysates Protein 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 H20 Contains DHA and AA Pregestimil – – – – 20cal/oz MCT (55%), safflower, soy corn syrup solids, corn starch Casein Hydrolysatenonantigenic peptides 19 g/L – Iron 12mg/L – Vitamin D 405 IU/L – 330 mOms/kg H20 – Does not have DHA and AA Other Hydrolysates Other Alimentum Advance – For infants and children with severe food allergies, For 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 H20 – Contains DHA and ARA – Lactose free (contains sucrose) Nutramigen LIPIL – – hypoallergenic hypoallergenic for infants who are sensitive to intact protein for in milk and soy-based formulas in – 270 mOms/kg H20 – Lactose and sucrose free Lactose New Kid on the Block! Enfamil Gentlease LIPIL Enfamil – Launched in July 05 – “iis a nutritionally balanced, milk-based s infant formula designed as a first switch formula for babies who have fussiness or gas.” – Partially broken down proteins Partially 6-9% hydrolyzed 6-9% – Reduced lactose 1/4 of typical – Whey:casein ratio of 60:40 – Contains DHA and ARA, “nutrients also found in Contains breast milk that promote brain and eye development.” breast – No studies to document efficacy in the intended No population population Elemental Formulas Elemental Indications: For infants and children who Indications: 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 Elemental Elemental 5% MCT Breast milk 33% MCT Neocate/Elecare – – – – 20cal/oz Human milk fat Lactose 70%whey 30%casein 9 g/L – Iron 0.3mg/L – Vit D 21 IU/L Vit – 260 mOsm/kg H20 – – – – – Contains DHA and AA – Do not contain DHA and Do AA AA 20cal/oz MCT, safflower, soy Corn syrup solids 100% free amino acids, 100% 21 g/L 21 – Iron 12mg/L – Vitamin D 500 IU/L – 335 mOsm/kg H20 Premature Formulas Premature NICU – Similac Special Care Similac Enfamil Premature Lipil Enfamil 20 and 24 kcal/oz Available only for inpatients Cow milk based 40% of fat is MCT Products are not appropriate for Products larger babies (2.5-3 kg) because of higher amounts of vitamins (esp A and D) and minerals (esp Premature Infants Premature Hospital discharge – NeoSure – EnfaCare 22 kcal/oz 22 Pro, calcium, phosphorus, MCT (20%) phosphorus, Cow milk based Improved growth – Wheeler, RE. Journal of Perinatology, Wheeler, 16:111-116, 1996. 16:111-116, Others Others Enfamil AR – Milk-based standard formula Milk-based – added rice starch that thickens in the acid added environment of the stomach – For babies who spit up frequently or need For a thickened formula thickened – Reduced reflux symptoms Reduced Vanderhoof , Clin Pediatr. 2003;42:483-495. Vanderhoof Isomil DF Isomil – Soy protein, soy fiber – For firming loose, watery stools in infants For older than 6 months and toddlers. older duration of antibiotic-induced diarrhea duration Burks, J Pediatr. 2001;139(4):578 Burks, Others Others Enfamil LactoFree – Milk-based – Lactose and sucrose-free formula for infants Lactose with fussiness, gas or diarrhea due to lactose sensitivity. sensitivity. – Calcium absorption was less than with lactose Calcium containing formula but total calcium absorption was adequate (Abrams, AJCN;2002) AJCN;2002) – Studies on efficacy have been mixed Generic Formulas Generic Must meet requirements set Must under the infant formula act – Minimums and maximums Less expensive Specialized Specialized Portagen (Mead Johnson) – 86% MCT oil fat malabsorption, intestinal lymphatic 86% obstruction, or chylothorax obstruction, – 2002 recall after the death of a premature infant from 2002 Enterbacter sakazakii contaminated formula. – Manufacturer no longer recommends for infants RCF (Ross) Ross Carbohydrate Free – – – Infants with CHO intolerance Must add CHO Modified for the ketogenic diet Specialized, cont: Specialized, Similac PM 60/40 – For infants with hypocalcemia For due to hyperphosphatemia or impaired renal function. Metabolic Formulas Metabolic – PKU, MSUD, tyrosinemia, PKU, homocystinuria, glutaric aciduria, PPA/MMA, urea cycle PPA/MMA, – Ross, Mead Johnson, Ross, Scientific Hospital Supplies Scientific Toddler Formulas Toddler Formulas Milk and soy based Milk products products for infants and toddlers – 9-24 months – who are eating solid foods Contain DHA and ARA Has > twice the calcium of Has regular infant formulas (300 mg vs 125 mg) Alternatives to Infant Formulas Alternatives Evaporated Milk Formula – AAP does not support its use Poorly digested fat Low iron and vitamin C Excessive sodium, protein, PO4 – Preferable to unmodified cow milk – Recipe 13 oz can 19.5 oz water 3 Tablespoons sugar or corn syrup – Requires supplementation with vitamins A, D, Requires calcium, and iron calcium, 10.5 mo old female with hx 10.5 of poor growth of – 26.5 weeks gestation – 3 mo NICU course mo complicated by poor feeding, BPD, hernia repair, seizures BPD, Discharged on Elecare and O2 7.5 mo corrected age – Meds—synthroid, zantac, Meds—synthroid, Poly-vi-sol, flovent, calcium gluconate gluconate Case Case Weight--5 kg Length-- 61.6 cm Length-IBW--6.5 kg 77% of IBW Dietary data Dietary – Family had switched to goat Family milk 1 mo prior on the advice of “someone” who said it would provide more nutrition provide – She was drinking more volume – 1 pound weight loss in 1 month pound loss 24-hr dietary intake – 20 oz of goat milk 20 (rice cereal added at 1T per 4 oz) 1T – 3 T baby solids Dietary Analysis Dietary Actual Needed Calories 425 (85/kg) 650 min Protein 22 (4.4/kg) 15-18 Cal dist: For 6-12 mo Protein 20 15 CHO 30 45-55 Fat 50 35-45 Formulas vs Goat Milk Formulas Nutrient/8 oz Calories Protein, g CHO, g Fat, g Sodium,mg Iron, mg Vitamin C,mg Folate, μg Folate, Vitamin D, IU Osmolality *Added NeoSure 180 4.6 (10%) 18.5 (41%) 18.5 9.8 (49%) 41 2.2 18 31 86 224 Goat Milk 140 8 (23%) 11 (31%) 11 7 (46%) 115 0 0 80 * 100 * 339 Elecare 180 5.3 (14%) 19 (43%) 8.5 (43%) 81 3.2 16 53 77 330 Choose the appropriate formula: Choose 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 Infant bile salts bile – Portagen Infant with ↓ renal fx and ↑ electrolytes Infant – Similac PM 60/40 Resources Resources Infant Formula: Evaluating the Safety of New Infant Ingredients (2004) Ingredients Food and Nutrition Board, Institute of Medicine – Infant Feedings: Guidelines for Preparation of Infant Formula and Breastmilk in Health Care Facilities. Robbins and Beker (eds), ADA 2003 Facilities. – The End! ...
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