A novel human milk fortifier supports adequate growth in very low birth weight infants: a non-inferiority randomised controlled trial.

ABSTRACT:

Objective

To compare growth, tolerance and safety parameters in very preterm infants receiving human milk (HM) fortified with a multicomponent cow's milk-based HM fortifier (HMF; control) versus a novel HMF-containing lipids (including docosahexaenoic acid and arachidonic acid), higher protein and lower carbohydrate levels (test). Our hypothesis was that weight growth velocity in the test group would be non-inferior to that in the control group.

Design

Double-blind, randomised controlled trial.

Setting

Nine European neonatal intensive care units.

Patients

HM-fed infants born at <32-week gestational age.

Interventions

Fortification of HM with Test or Control HMF for a minimum of 21 days.

Primary outcome

Weight growth velocity between baseline and i

SUBMITTER: Picaud JC 

PROVIDER: S-EPMC12418532 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature