Plant-derived fortifier showed faster in-hospital weight gain—but the formulation changed more than protein source

A 136-infant pilot RCT found 3.20 g/kg/day higher adjusted weight gain to discharge with a plant-derived amino acid fortifier. The products also differed in energy, protein, fat, and micronutrients; the gap vanished by 40 weeks PMA, and safety estimates were too imprecise for equivalence.

THE HOT TAKE

The trial found a short in-hospital weight-velocity signal, but the intervention changed the nutrient package—not just the protein source.

Published on 4 August 2026, this prospective open-label pilot RCT enrolled preterm infants born before 34 weeks who had started mother's own milk or pasteurized donor milk within 48 hours. Two tertiary NICUs in India randomized 136 infants: 66 to a plant-derived free-amino-acid fortifier and 70 to a bovine whey-protein fortifier. The primary intention-to-treat analyses used 50 multiply imputed datasets and adjusted for gestational age, birth weight, antenatal corticosteroids, and antenatal umbilical-artery Doppler abnormalities.

From enrollment to discharge, the unadjusted mean difference was 3.20 g/kg/day (95% CI −0.33 to 6.73; P=0.08). After covariate adjustment, the point estimate remained 3.20 but the interval narrowed to 0.46 to 5.95 g/kg/day (P=0.02). By 40 weeks PMA, the adjusted difference was 0.03 g/kg/day (95% CI −0.85 to 0.92; P=0.95). The chart therefore shows a transient imputed mean difference, not a durable growth advantage.