utriBrain: A controlled study to investigate the effect of a food product on brain development in very early born infants

Not Applicable

• Conditions: Extremely and very preterm infants (born between 24 week and 30 weeks of pregnancy); Neonatal Diseases

• Registration Number: ISRCTN96620855
• Lead Sponsor: utricia Research

Brief Summary

2021 protocol in https://pubmed.ncbi.nlm.nih.gov/33731062/ (added 21/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Last Update Posted: 3 May 2021
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Current inclusion criteria as of 21/04/2021:
1. Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected date of delivery)
2. Less than 72 h old, and the intention to receive the first administration of study product between 48-72 h after birth
3. Written informed consent from custodial parent(s)
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Previous inclusion criteria:
1. Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected date of delivery)
2. Less than 72 hours old, and the possibility to receive the first administration of study product between 48-72 hours after birth
3. Written informed consent from custodial parent(s)

Exclusion Criteria

Current exclusion criteria as of 21/04/2021:
1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation
2. Presence of a congenital central nervous system infection
3. Presence of any gastrointestinal malformation
4. No realistic prospect of survival
5. Concomitant participation in other intervention studies (for example, but not exclusively, those studies involving investigational or marketed nutritional or pharmaceutical products) that could impact on the main outcome parameters and/or subject safety
6. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions
7. Admission from an extra regional hospital, unless that hospital is a study site
8. Current use of gastric acid inhibitors: H2-receptor antagonists (including ranitidine) or proton pump inhibitors (including omeprazole)

_____

Previous exclusion criteria:
1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation
2. Presence of a congenital central nervous system infection
3. Presence of any gastrointestinal malformation
4. No realistic prospect of survival
5. Concomitant participation in other intervention studies (for example, but not exclusively, those studies involving investigational or marketed nutritional or pharmaceutical products) that could impact on the main outcome parameters and/or subject safety
6. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions
7. Admission from an extra regional hospital, unless that hospital is a study site
8. Current use of anti-reflux medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified