Continuity Clinic
Infant Formulas
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Continuity Clinic
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
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Infant Formula
• Product intended for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk
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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
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1966—1st 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
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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.
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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.
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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
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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
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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
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Whey to Casein Ratio% Whey % Casein
Breast milk 70 -lactalbumin, lactoferrin, IgA
30
β-casein
Enfamil 60 40
Similac 18 82
Carnation
Good Start
100 0
Soy 0 0
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Standard FormulaFeatures
• 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 H20
– 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 H20
– DHA and AA added • Formulas still made without
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Standard FormulaFeatures
• 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 H20
– 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 H20
– DHA and AA added • Formulas still made without
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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
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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)
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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 H20– 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 H20
– DHA and AA added
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Protein Hydrolysates
• Hydrolyzed casein or whey protein
• Various fat blends
• All are lactose free
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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 H20– 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 H20
– Does not have DHA and AA
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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 H20– 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 H20– Lactose and sucrose free
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New Kid on the Block!
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• 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
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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
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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 H20
– 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 H20
– Do not contain DHA and AA
5% MCT 33% MCT
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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
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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.
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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
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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
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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
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Generic Formulas
• Must meet requirements set under the infant formula act – Minimums and maximums
• Less expensive
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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
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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)
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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
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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
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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