A novel human milk fortifier derived from donkey milk for the nutrition of preterm or low-weight newborns

Not Applicable

Completed

• Conditions: Enteral nutrition in very low birthweight infants; Neonatal Diseases

• Registration Number: ISRCTN70022881
• Lead Sponsor: SC Neonatologia, University of Turin

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Study Completion: 2018-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of at least one episode of alimentary intolerance, defined as the necessity to interrupt enteral feeding for more than 8 consecutive hours during the study period from T0 to T3 (day 21)