Oral Formulation of Insulin for Preterm Infants

Phase 2

Terminated

• Conditions: Premature Birth of Newborn
• Interventions: Biological: Oral Formulation of Insulin; Biological: Placebo

• Registration Number: NCT01093638
• Lead Sponsor: Elgan Pharma Ltd.

Brief Summary

The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

Detailed Description

The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.

Study Timeline

• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Study Start: 2010-08
• Primary Completion: 2013-08
• Study Completion: 2016-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Pre-term infants 26-33 weeks gestation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Formulation of Insulin	Oral Formulation of Insulin	Oral formulation of insulin fed concomitantly with premature infant formula
Oral Formulation of Placebo	Placebo	Oral formulation of placebo fed concomitantly with premature infant formula

Primary Outcome Measures

Name	Time	Method
Number of days to achieve complete enteral feeding	Up to 28 days or discharge and at 3 months of age

Secondary Outcome Measures

Name	Time	Method
Number of gastric residual > 2 ml/kg	Up to 28 days or discharge, at 3 months of age
Number of days to discharge	Up to 28 days or discharge and at 3 months of age
Number of gastric residual > 50% of previous feeding	Up to 28 days or discharge and at 3 months of age
Weight gain	Up to 28 days or discharge and at 3 months of age

Trial Locations

Locations (1)

NICU, Laniado Hospital; 🇮🇱 Netanya, Israel