Vanderbilt Clinical Trials

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.	Drug: NTRA-2112
Experimental NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.	Drug: NTRA-2112
Placebo Comparator Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.	Drug: Placebo

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.