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A Novel Donkey Milk-Derived Human Milk Fortifier in Feeding Preterm Infants

A Randomized Controlled Trial

Bertino, Enrico*; Cavallarin, Laura; Cresi, Francesco*; Tonetto, Paola*; Peila, Chiara*; Ansaldi, Giulia*; Raia, Melissa*; Varalda, Alessia*; Giribaldi, Marzia†,‡; Conti, Amedeo; Antoniazzi, Sara; Moro, Guido E.§; Spada, Elena*; Milani, Silvano||; Coscia, Alessandra*

Journal of Pediatric Gastroenterology and Nutrition: October 12, 2018 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/MPG.0000000000002168
Clinical Trials: Nutrition: PDF Only

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 <32 weeks of gestational age and/or with a birthweight ≤1500 g. Newborns were randomized 1:1 to receive enteral feeding with either a bovine milk-based fortifier (BF-arm), or a new, donkey milk-derived fortifier (DF-arm) for 21 days. The fortification protocol was the same for both study arms, and the two 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% 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.

URL and Trial Identification Number:, ISRCTN70022881

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

*Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, Turin 10126, Italy

Institute of Sciences of Food Production, Italian National Research Council, Largo Braccini 2, 10095 Grugliasco (TO) Italy

Research Centre for Engineering and Agro-Food Processing, Council for Agricultural Research and Economics (CREA), Strada delle Cacce 73, 10135 Turin, Italy

§Italian Association of Human Milk Banks, Via Libero Temolo 4, Milan 20126, Italy

||Laboratory of Medical Statistics, Biometry & Epidemiology “GA Maccacaro”, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

Address correspondence and reprint requests to Laura Cavallarin, MS, Institute of Sciences of Food Production, Italian National Research Council, Largo Braccini 2, 10095 Grugliasco (TO) Italy (e-mail:

Received 7 May, 2018

Accepted 17 September, 2018

Conflicts of Interest and Source of Funding:

This work was supported by Compagnia di San Paolo, Italy, Award n. 2539 to EB.

EB, LC, GEM, AC have competing interest since they are the inventors of a patent on the fortifier derived from donkey milk described in the paper (Italian Patent no. n.0001421271 and international patent application no. WO2015056166 (A1)-20,150,423).

No conflicts of interest exists for the remaining authors.

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© 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,