To assess the efficacy of 2 doses of NTRA-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.

Phase 1

Active, not recruiting

• Conditions: Gastro Intestinal Malabsorption in Preterm Infants.; MedDRA version: 20.1Level: PTClassification code 10025476Term: MalabsorptionSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10025479Term: Malabsorption syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-002624-28-IT
• Lead Sponsor: TRINIA LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

1. Male or female pre-term infant 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound *
2. Birth weight = 500g
3. Singleton or twin birth
4. Postnatal age up through and including Day 5
5. Fraction of inspired oxygen = 0.60 at enrolment
6. The infant is in a cardiovascular stable condition
7. Infant is able to take enteral feed
8. Infant is expected to wean off PN at the primary hospital
9. Informed consent form signed by parents or legal guardian
10. In the Investigator’s opinion, is able to comply and sufficiently stable to partake in the trial to completion
* If both exist and difference > 2 weeks, based on early antenatal ultrasound
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Complete enteral feeding
2. Major congenital malformation (i.e., infants with genetic, metabolic, or endocrine disorder diagnosed before enrolment
3. High index of suspicion of infection before enrolment
4. Intra-uterine growth retardation (IUGR) defined as either weight for gestational age less than the third percentile or less than the 10’th percentile with Doppler abnormalities in utero **.
5. Confirmed necrotizing enterocolitis (NEC)
6. Maternal diabetes (Type I/II or gestational).
7. Any systemic insulin administration after birth.
8. Nothing per os (NPO) for any reason at study entry.
9. Heart and chest compression or any resuscitation drugs given to the infant during delivery
10. Participation in another interventional clinical study that may interfere with the results of this trial
**According to Fenton preterm growth chart

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified