Objective: To evaluate growth, safety and tolerance of a preterm infant formula supplemented with ARA and DHA from microbial fermentation oils.

Methods: In a prospective, randomized, parallel, double blind, multicenter trial, infants 750-2000 g exclusively received (fortified) human milk (HM), a 24 Kcal/oz control preterm formula (C) or the same preterm formula with ARA and DHA (LCP). Daily weights (wt) and weekly measurements of Length (lgth) and Head Circumference (hc) were done during hospitalization and at 40 wks post Conceptional Age (PCA). Serum chemistries were measured at full feeds (≥ 150 ml/kg/day; mean = 33 wks PCA for all groups) and 40 wks PCA(see Table, different scripts = p < 0.05).

Table 1
Full size table

Results: Significant differences were noted in all measures of growth between the HM and the formula groups, but no statistically significant differences were found between the two formula groups in anthropometric measurements or serum chemistries. Study events were similar between the two formula groups, including those related to gastrointestinal symptoms(diarrhea, increased gastric residuals, vomiting) and those resulting in withdrawal from study (10 C, 11 LCP, 8 HM).

Conclusion: Data substantiates that a premature formula supplemented with ARA (0.6%) and DHA (0.4%) from microbial fermented oil is safe and supports normal growth.Supported by Wyeth Nutritionals International