To assess the efficacy of NTRA-2112 on intestinal malabsorption due to gastro-intestinal immaturity by measuring the time required to reach full enteral feeding in preterm infants during the treatment period compared to a placebo formulation.

Phase 1

• Conditions: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.; MedDRA version: 20.1Level: LLTClassification code 10025479Term: Malabsorption syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; 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; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-002624-28-FR
• Lead Sponsor: utrinia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-15
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Pre-term infants 26 and up to 32 weeks gestation.
2. Birth weight = 500 gr.
3. Postnatal age up to 5 days.
4. Fraction of inspired oxygen = 0.60 at enrolment.
5. The infant is in a cardiovascular stable condition.
6. Infant is able to take enteral feed.
7. No heart and chest compression or any resuscitation drugs given to the infant during delivery.
8. Patient 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 with the trial requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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 – 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 weight for gestational age 5. Confirmed NEC.
6. Maternal diabetes (Type I/II or gestational).
7. The infant is treated with Insulin.
8. NPO, nothing per os for any reason at the 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.
11. In the Investigator’s opinion, is not able to comply with the trial requirements.

Study & Design

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