Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial

Abstract

BackgroundFortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow’s milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier.The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins.MethodsThe study has been designed as a randomized, controlled, single-blind clinical trial. Infants born <1500 g and <32 weeks of gestational age were randomized to receive for 21 days either a combination of control bovine milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored.DiscussionThis is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding tolerance or either of the clinical, metabolic, neurological or auxological outcomes of preterm infants, it would be an absolute innovation in the field of feeding practices for preterm infants.Trial registrationISRCTN -ISRCTN70022881.

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

“…The recruitment period was 27 November 2014 to 22 December 2016. All the details about the clinical trial have been deeply described in two previous reports [18,20]. The present research was performed in a subpopulation of the original cohort that successfully completed the study period and whose urinary samples at the beginning of fortification (Time 0) and 21 days later (Time 1) were available.…”

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.…”

“…(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.…”

“…Composition of BF and DF -Values per 100 g of product Details on eligibility criteria, sample size calculation, settings and randomization and are specified in the FortiLat trial (15). This study follows ed the Consolidate Standards of Reporting Trials.…”

Analysis of Environmental Factors’ Impact on Donkeys’ Colostrum Quality

“…In the last decade, because of anti-allergenic properties, mainly in infants exhibiting Cow Milk Protein Allergy [52][53][54], donkey milk has received interest as a breast milk substitute, mainly due to its colostrum content. Thus, the study of the β-lactoglobulin, identified in two molecular forms-β-lactoglobulin I, and β-lactoglobulin II-in donkey milk and colostrum, respectively [55].…”