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
- Conditions
- Intestinal malabsorption in pre-term infantsTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2014-002624-28-GB
- Lead Sponsor
- utrinia Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 530
1. Male or female pre-term infants 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 PN at the primary hospital.
9. Informed consent form (ICF) 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 as required until trial 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
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-
Defined as positive blood culture, Leukocytosis >30,000 and Leukopenia <4,000.
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. According to Fenton preterm growth chart (see Appendix D). If no in utero Doppler study is available for infants with IUGR between third and 10’th percentile of Fenton preterm growth charts, the infant will be eligible to participate in the study.
5. Confirmed necrotizing enterocolitis (NEC).NEC is characterized by the sudden onset of gastrointestinal distress that may include symptoms such as vomiting, abdominal distention, bloody stools, or dilated loops of bowel that leads to cessation of enteral feedings.
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 the 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method