A randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants

utricia Research0 sites88 target enrollmentOctober 10, 2017

Overview

Registry

who.int

Start Date

October 10, 2017

End Date

April 1, 2025

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

utricia Research

•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)
•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)

•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: