Randomized controlled clinical trial in single-blind to evaluate the nutritional adequacy of a novel human milk fortifier derived from donkey milk for the nutrition of preterm or low-weight newborns

SC Neonatologia, University of Turin0 sites124 target enrollmentMay 10, 2017

Overview

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29316931 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30320665 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761645/ follow results at 18 months (added 14/06/2023) 2020 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400944/ gastroesophageal reflux additional results (added 14/06/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32727157/ metabolomic profile results (added 14/06/2023) 2020 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764145/ neurodevelopmental outcome at 18 months (added 14/06/2023)

Registry

who.int

Start Date

May 10, 2017

End Date

January 1, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

SC Neonatologia, University of Turin

•1\. Gestational age \< 32 weeks, or birthweight \< 1500 grams
•2\. Feeding with human milk (fresh or donor) \> 80% of the total
•3\. Enteral feeding \=80ml/kg/d of human milk reached within the first 4 weeks of life
•4\. Informed consent by a parent

•1\. Severe gastrointestinal pathologies (diagnosed or suspect necrotizing enterocolitis, colostomy, intestinal obstruction, symptoms of peritonitis, presence of blood in the feces)
•2\. Chromosomal abnormalities or major malformations
•3\. Hereditary metabolic pathologies
•4\. Intravascular disseminated coagulation (IDC), shock
•5\. Patent Ductus Arteriosus (PDA) requiring medical care or surgery
•6\. Severe renal insufficiency (serum creatinine \> 2 mg/dl)