Aim: To evaluate a new HMF (WNI) that differs in composition from a reference standard HMF, Mead Johnson Enfamil® (MJ).

Design: Open, randomized, controlled, multicenter.

Subjects: 64 low birth weight (LBW) infants completed study: GA 26-32 weeks; BW 783-1541 g; Feedings: >145 ml/kg/d human milk (HM) only.

Interventions: HMFs: WNI [n=35; [horizontal bar over]x intake=144 ml/kg/d fortified HM (≅2.8 g total protein/kg/d) for [horizontal bar over]x 21 days]; MJ [n=29; [horizontal bar over]x intake=154 ml/kg/d fortified HM(≅2.6 g total protein/kg/d) for [horizontal bar over]x 22 days].

Outcomes: Growth parameters, serum chemistries, Vitamin D, Cu.

Results: WNI group had significantly greater (p<.05) increase in weight(WNI 26.8±1.3 g/d, MJ 20.4±1.2 g/d) and head circumference (WNI 1±0.1 cm/wk, MJ 0.8±0.1 cm/wk). All chemistries were normal and acceptable for age. Study events were typical of premsturity and similar for WNI and MJ in 1 of infants.

Conclusions: This study demonstrates enhanced growth with WNI HMF compared to MJ with comparable safety.