A Novel Donkey Milk–derived Human Milk Fortifier in Feeding Preterm Infants

Abstract

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.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% confidence interval: −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 in 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−1 · day−1) and daily weight increase between the first day of exclusive enteral feeding (ie, without administering intravenous fluids) and discharge were similar in the BF- and DF-arms.Conclusions:These results suggest that DF improve feeding tolerance when compared with standard bovine-derived fortifiers, with a similar auxological outcome.

Urinary Metabolomic Profile of Preterm Infants Receiving Human Milk with Either Bovine or Donkey Milk-Based Fortifiers

“…Table 2 reports the main clinical outcomes following ADJ fortification in the two groups. The relative risk (RR) ratio for the primary outcome of the original clinical study [18], i.e., the occurrence of at least one feeding intolerance episode, was calculated in the subpopulation. The RR ratio for feeding intolerance, defined as interruption of enteral feeding for at least eight consecutive hours during the observation period, was found to be 0.40 in the D-HMF group, equal to that reported in the main clinical trial.…”

“…Recently, we have shown that preterm and VLBW infants receiving isocaloric and isoproteic supplementation of HM with either bovine milk-based fortifier (B-HMF) or experimental donkey milk-based fortifiers (D-HMF) achieve similar auxological outcomes. Additionally, a donkey milk-based fortifier significantly reduced the occurrence of feeding intolerance, feeding interruptions, bilious gastric residuals and vomiting [18]. As an extension of our previous study, the current investigation aims at applying the metabolomics approach to explore the modulation of the two above-mentioned fortifiers on the metabolic phenotype of preterm infants after a 21-day period of adjustable (ADJ) fortification.…”

Effects on gastroesophageal reflux of donkey milk-derived human milk fortifier versus standard fortifier in preterm newborns. Additional data from Fortilat study.

“…Median value for bradycardia was 67 (63-78) beats per minute with a lowest of 58 beats per minute. The median duration of apnea events was 12 (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) seconds, the longest apnea recorded was 38 seconds long. Detailed CR monitoring data are reported in Table 3.…”

“…This study suggests that DF improves feeding tolerance when compared with standard BF showing a lower number of failures (necrotizing enterocolitis, FI, death) and lower risk of FI episodes. (14) The evaluation of GER and gastric emptying, as a marker of FI, was evaluated by multichannel intraluminal impedance and pH monitoring (MII/pH) and gastric ultrasound (US) as secondary endpoints of the FortiLat trial. (14,15) Aim of this study is to evaluate the effects of the DF on VLBW and very preterm infants enrolled in the FortiLat trial with symptoms of GER and CR events.…”

The Rediscovery of Donkey's Milk as Healthy Food for Different Life Stages

“…The nutritional similarities with human milk, the gold standard for infant feeding, are also encouraging for other uses in children diet. Recently, a fortifier derived from donkey milk for preterm infants (which have suboptimal actual protein intake from breast milk) has been developed [3].…”