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

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

• Registration Number: EUCTR2014-002624-28-BE
• Lead Sponsor: utrinia Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-08
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot 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 (up to 120 hours post birth)
5.Fraction of inspired oxygen = 0.60 at enrolment
6.Subjects must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require >40% oxygen with blood pressure support and the need for umbilical artery cauterization
7.Infant is able to tolerate enteral feed
8.Infant is expected to wean off parenteral nutrition (PN) at the primary hospital
9.Informed consent form signed by parents or legal guardian
10.In the Investigator’s opinion, the infant is able to comply with the study procedures 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: 530
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Complete enteral feeding
2.Major congenital malformation (e.g., infants with genetic, metabolic, and/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 10th percentile with Doppler abnormalities in utero ***.
5.Confirmed necrotizing enterocolitis (NEC)
6.Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
7.Hyperinsulinemia requiring glucose administration of more than 12mg/kg/min at randomization.
8.Any systemic insulin administration at randomization.
9.Nothing per os (NPO) for any reason at study entry.
10.Heart and chest compression or any resuscitation drugs given to the infant during delivery
11.Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
12.Participation in another interventional clinical study that may interfere with the results of this trial
**Defined as positive blood culture, Leukocytosis >30,000 and Leukopenia <4,000.
***According to Fenton preterm growth chart (see Appendix D). If no Doppler in utero is available for infants with IUGR between third and 10’th percentile of Fenton preterm growth charts, infant is eligible to participate in the study.

Study & Design

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