A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants.

Phase 3

Completed

• Conditions: 10025477; prematuratie; intestinal malabsorption in preterm infants

• Registration Number: NL-OMON46903
• Lead Sponsor: utrinia Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Numbers of days to achieve full enteral feeding, defined as the ability of the<br /><br>preterm infant to achieve enteral feeding at least 150 ml/kg/day for 3<br /><br>consecutive days.<br /><br><br /><br>Sub-study sugar absorption test:<br /><br>lactase activitity en intestinal permeability</p><br>