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

Phase 2

Recruiting

Conditions: brain development in preterm infants
brain maturation in preterm infants
10027665
10004018
10010335

Registration Number: NL-OMON55507

Lead Sponsor: utricia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 98

Inclusion Criteria

- Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected
date of delivery)
- Less than 72 hours old, and the intention to receive the first administration
of study product between 48-72 hours after birth
- Written informed consent from custodial parent(s)

Exclusion Criteria

- Any relevant proven or suspected chromosomal anomaly, metabolic disorder,
genetic syndrome or congenital central nervous system malformation
- Presence of a congenital central nervous system infection
- Presence of any gastrointestinal malformation
- No realistic prospect of survival
- 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
- Expected or foreseen inability of the subject and/or their families to adhere
to protocol instructions
- Admission from an extra regional hospital, unless that hospital is a study
site
- Currrent use of gastric inhibitors: H2-receptor antagonists (including
ranitidine) or proton pump inhibitors (including omeprazole)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>During the intervention period (from randomisation until and including TEA):<br /><br>Tract-Based Spatial Statistics analysis using the diffusion weighted imaging to<br /><br>investigate the difference in fractional anisotropy at TEA between the test<br /><br>group and control group </p><br>

Secondary Outcome Measures