Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Purpose
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
Conditions
- Premature Birth of Newborn
- Intestinal Malabsorption
Eligibility
- Eligible Ages
- Between 1 Day and 5 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Complete enteral feeding
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NTRA-2112 A |
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. |
|
|
Experimental NTRA-2112 B |
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. |
|
|
Placebo Comparator Placebo |
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. |
|
More Details
- Status
- Unknown status
- Sponsor
- Nutrinia
Study Contact
Detailed Description
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo