Continuity Clinic

Infant Formulas

Continuity Clinic

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

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

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

Continuity Clinic

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

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.

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.

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

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

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

Continuity Clinic

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

Continuity Clinic

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

Continuity Clinic

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

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

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)

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 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

Continuity Clinic

Protein Hydrolysates

• Hydrolyzed casein or whey protein

• Various fat blends

• All are lactose free

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 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

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 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

Continuity Clinic

New Kid on the Block!

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

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

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 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

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

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.

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

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

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

Continuity Clinic

Generic Formulas

• Must meet requirements set under the infant formula act – Minimums and maximums

• Less expensive

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

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)

Continuity Clinic

Continuity Clinic

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

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

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