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Clinical Trials/NL-OMON55507
NL-OMON55507
Recruiting
Phase 2

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

utricia0 sites98 target enrollmentTBD
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Conditionsbrain development in preterm infantsbrain maturation in preterm infants100276651000401810010335

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
brain development in preterm infants
Sponsor
utricia
Enrollment
98
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
utricia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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