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Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial.
Nutr J. 2018 01 09; 17(1):6.NJ

Abstract

BACKGROUND

Fortification 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.

METHODS

The 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.

DISCUSSION

This 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 REGISTRATION

ISRCTN - ISRCTN70022881 .

Authors+Show Affiliations

Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy.Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy.Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy.Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy. peila.chiara@gmail.com.Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy.Italian Association of Human Milk Banks, Via Libero Temolo 4, 20126, Milan, Italy.Italian Association of Human Milk Banks, Via Libero Temolo 4, 20126, Milan, Italy.Neonatal Unit of Turin University, City of Health and Science of Turin, Via Ventimiglia 3, 10126, Turin, Italy.Unit of Medical Statistics and Biometry, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.Institute of Sciences of Food Production, 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.Institute of Sciences of Food Production, National Research Council, Largo Braccini 2, 10095, Grugliasco (TO), Italy.Institute of Sciences of Food Production, National Research Council, Largo Braccini 2, 10095, Grugliasco (TO), Italy.Institute of Sciences of Food Production, National Research Council, Largo Braccini 2, 10095, Grugliasco (TO), Italy.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29316931

Citation

Coscia, Alessandra, et al. "Nutritional Adequacy of a Novel Human Milk Fortifier From Donkey Milk in Feeding Preterm Infants: Study Protocol of a Randomized Controlled Clinical Trial." Nutrition Journal, vol. 17, no. 1, 2018, p. 6.
Coscia A, Bertino E, Tonetto P, et al. Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial. Nutr J. 2018;17(1):6.
Coscia, A., Bertino, E., Tonetto, P., Peila, C., Cresi, F., Arslanoglu, S., Moro, G. E., Spada, E., Milani, S., Giribaldi, M., Antoniazzi, S., Conti, A., & Cavallarin, L. (2018). Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial. Nutrition Journal, 17(1), 6. https://doi.org/10.1186/s12937-017-0308-8
Coscia A, et al. Nutritional Adequacy of a Novel Human Milk Fortifier From Donkey Milk in Feeding Preterm Infants: Study Protocol of a Randomized Controlled Clinical Trial. Nutr J. 2018 01 9;17(1):6. PubMed PMID: 29316931.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial. AU - Coscia,Alessandra, AU - Bertino,Enrico, AU - Tonetto,Paola, AU - Peila,Chiara, AU - Cresi,Francesco, AU - Arslanoglu,Sertac, AU - Moro,Guido E, AU - Spada,Elena, AU - Milani,Silvano, AU - Giribaldi,Marzia, AU - Antoniazzi,Sara, AU - Conti,Amedeo, AU - Cavallarin,Laura, Y1 - 2018/01/09/ PY - 2017/05/23/received PY - 2017/12/15/accepted PY - 2018/1/11/entrez PY - 2018/1/11/pubmed PY - 2019/6/6/medline KW - Adjustable fortification KW - Donkey milk KW - Enteral feeding KW - Feeding intolerance KW - Human milk KW - Human milk fortifier KW - Preterm infants KW - VLBW infants SP - 6 EP - 6 JF - Nutrition journal JO - Nutr J VL - 17 IS - 1 N2 - BACKGROUND: Fortification 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: ISRCTN - ISRCTN70022881 . SN - 1475-2891 UR - https://www.unboundmedicine.com/medline/citation/29316931/Nutritional_adequacy_of_a_novel_human_milk_fortifier_from_donkey_milk_in_feeding_preterm_infants:_study_protocol_of_a_randomized_controlled_clinical_trial_ L2 - https://nutritionj.biomedcentral.com/articles/10.1186/s12937-017-0308-8 DB - PRIME DP - Unbound Medicine ER -