Evaluation of a long-chain polyunsaturated fatty acid supplemented formulaon growth, tolerance, and plasma lipids in preterm infants up to 48 weeks postconceptional age

Background: The last trimester of pregnancy is a period of rapid accretion of long-chain polyunsaturated fatty acids, both in the central nervous syst em and the body as a whole. Human milk contains these fatty acids, whereas some preterm infant formulas do not. Infants fed formulas without these fat ty acids have lower plasma and erythrocyte concentrations than infants fed human milk. Preclinical and clinical studies have demonstrated that single- cell sources (algal and fungal) of long-chain polyunsaturated fatty acids a re bioavailable. A balanced addition of fatty acids from these oils to pret erm formula results in blood fatty acid concentrations in low birth weight infants comparable to those of infants fed human milk. Methods: In the present study the growth, acceptance (overall incidence of discontinuation, reasons for discontinuation, overall incidence and type of individual adverse events), and plasma fatty acid concentrations were comp ared in three groups of infants fed a long-chain polyunsaturated fatty acid -supplemented preterm infant formula, an unsupplemented control formula, or human milk. The study was prospective, double-blind (formula groups only), and randomized (formula groups only). Two hundred eighty-eight infants wer e enrolled (supplemented formula group, n = 77; control formula group, n = 78; human milk group, n = 133). Results: Anthropometric measurements at enrollment, at first day of full or al feeding, and at both 40 and 48 weeks postconceptional age did not differ between the formula groups, whereas the human milk-fed group initially gre w at a lower rate. The incidence of severe adverse events was rare and not significantly different between formula groups. The groups fed either human milk or supplemented formula had long-chain polyunsaturated fatty acid con centrations higher than those in the control formula group. Conclusions: The results of this study demonstrate the safety and efficacy of a preterm formula supplemented with long-chain polyunsaturated fatty aci ds from single-cell oils.