A Novel Donkey Milk-derived Human Milk Fortifier in Feeding Preterm Infants: A Randomized Controlled Trial

Objectives: The purpose of the present randomized controlled clinical trial was to compare the use of donkey milk-derived fortifier (DF) with commercial bovine milk-derived fortifier (BF) in very preterm or very-low-birth-weight newborns, in terms of feeding tolerance.Methods: This trial included 156 newborns born at <32 weeks of gestational age and/or with a birth weight <= 1500 g. Newborns were randomized 1: 1 to receive enteral feeding with either a BF-arm, or a new, DF-arm for 21 days. The fortification protocol was the same for both study arms, and the 2 diets were designed to be isoproteic and isocaloric. Feeding tolerance was assessed by a standardized protocol.