Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nutrinia

Criteria

Inclusion Criteria

1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound

2. Birth weight ≥ 500g

3. Singleton or twin birth

Exclusion Criteria

1. Complete enteral feeding