Objective: This prospective, parallel, randomized, double-blind, multicenter study compared growth, safety, and tolerance in preterm infants fed a new (E1) or standard (E2) 24 kcal/oz LBW infant formula. This was an outpatient continuation (Phase II) of an inpatient study (Phase I). Phase I was enrollment to hospital discharge at 36 weeks, and Phase II from hospital discharge to 40 weeks postconceptional age (PCA).

Methods: At enrollment, preterm infants were stratified into subgroups according to PCA (25-28 weeks; 29-31 weeks; 32-34 weeks) and then randomly assigned to 1 of 2 study formulas which were identical except for higher protein (22 g vs 20 g/L) and vitamin and mineral levels (1000 vs 800 mg Ca/L; 600 vs 425 mg P/L) in E1. Daily weights (Wt), weekly measurements of length (Lt) and head circumference (OFC) were obtained during Phase I, at hospital discharge, and at the end of Phase II. Serum chemistries were drawn at enrollment, biweekly during Phase I, at hospital discharge, and at the end of Phase II. Adverse events were monitored during the study.

Results: 106/133 infants completed Phase I, and 89 completed Phase II, Wt, Lt, OFC, formula intake, serum chemistries and the incidence of adverse events such as bradycardia, apnea, and anemia were similar in both formula groups.

Conclusion: The new E1 formula with higher protein, vitamin and mineral levels is safe, well tolerated, and supports nutrient absorption and retention comparable to a standard LBW formula (E2). Table

Table 1 No caption available.
Full size table