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 with commercial bovine milk-derived fortifier in very preterm or very low-birthweight newborns, in terms of feeding tolerance. Methods: This trial included 156 newborns born at Results: The risk of feeding intolerance tended to be lower in DF-arm than in BF-arm, with a relative risk reduction of 0.63 (95% CI: −0.29, +0.90). The mean number of episodes per newborn of feeding intolerance and feeding interruptions (any duration) were consistently lower in the DF-arm than the BF-arm. Episodes of bilious gastric residuals and vomiting were significantly lower in the DF-arm. Time needed to reach full enteral feeding (150 ml/kg/d) and daily weight increase between the first day of exclusive enteral feeding (i.e., without administering intravenous fluids) and discharge were similar in the BF- and DF-arms. Conclusions: These results suggest that donkey milk-derived fortifiers improve feeding tolerance when compared with standard bovine-derived fortifiers, with a similar auxological outcome. Conclusions: URL and Trial Identification Number: http://www.isrctn.com/ISRCTN70022881, ISRCTN70022881