CONCLUSIONS: SCIENTIFIC EVIDENCE SUPPORTS THE USE
OF SPECIAL FORMULAS FOR LOW-BIRTH-WEIGHT INFANTS A copy of the full report is available from this website,
without charge, as a PDF file.
Click here to download the report. Press Release Sufficient evidence may be available for FDA
to begin specifying nutrient content of
low-birth-weight infant formula (December 19, 2005) Bethesda, MD - Prematurity is the leading cause of newborn death. Premature and low-birth-weight (LBW) infants are fragile and require intensive medical care during the perinatal period until the baby is stable and growing adequately. Optimal nutrition care to support the health and growth of these infants is a critical component of this medical care.
The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety and nutritional quality of infant formulas. The FDA has not yet specified how formulas for LBW infants should differ, if at all, from specified contents for term infant formulas.
The Study
The new report, entitled Summary and Comparison of Recommendations for Nutrient Contents of Low-Birth-Weight Infant Formulas, was co-authored by Dr. Catherine Klein, a senior staff scientist at the Life Sciences Research Office, Inc. (LSRO), Bethesda, MD and Dr. William Heird, a pediatric physician at Baylor College of Medicine, Houston, TX.
The authors compared recommendations of the American Academy of Pediatrics Committee on Nutrition (AAPCON), the Canadian Paediatric Society (CPS), LSRO and others that specify nutritional requirements of preterm and LBW infants and/or recommendations for the nutrient content of infant formulas.
Findings
The composition standards for energy and many other nutrients in LBW infant formulas proposed by LSRO, AAPCON, CPS and a consensus group are different from those for term infant formulas because LBW infants are at a different stage of development and cannot consume as much formula. The recommended minimum content of protein (and specific amino acids), folic acid, vitamin C, several minerals, and fat soluble vitamins for LBW infant formulas is substantially higher than the content of these nutrients recommended for term infant formulas. For phosphorus, iron, zinc, and vitamin A the recommended minimum concentration of these nutrients for LBW infant formulas exceeds the respective maximum concentration recommended for term infant formulas.
While recommendations are in good agreement among the various expert groups for macronutrients, for some nutrients the difference in recommendations among groups varies by five-fold or more. For example, AAPCON, LSRO, the CPS, and a consensus group recommend minimum niacin intakes of > 300, 660, 756, and 3600 µg/kg d, respectively. Further research is needed to resolve these differences.
Conclusions
The composition standards for energy and many other nutrients in LBW infant formulas proposed by LSRO, AAPCON, CPS and a consensus group are different from those for term infant formulas because LBW infants are at a different stage of development and cannot consume as much formula. The recommended minimum content of protein (and specific amino acids), folic acid, vitamin C, several minerals, and fat soluble vitamins for LBW infant formulas is substantially higher than the content of these nutrients recommended for term infant formulas. For phosphorus, iron, zinc, and vitamin A the recommended minimum concentration of these nutrients for LBW infant formulas exceeds the respective maximum concentration recommended for term infant formulas.
Despite some differences among recommendations by various organizations, all the recommendations reflect that scientific knowledge warrants establishing standards for the nutrient content of LBW infant formulas that are distinct from the FDA standards used to regulate and manufacture term infant formulas. LBW infant formulas meeting the nutrient contents recommended by LSRO are available and already in use in the United States. However, continued research is needed to confirm the accuracy of current recommendations for virtually all nutrients in LBW infant formulas.
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