NCT01093638

Oral Formulation of Insulin for Preterm Infants

A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Elgan Pharma Ltd. · Industry
• Sex: All
• Age: 26 Weeks – 33 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Premature Birth of Newborn

Interventions

Type	Name	Description
BIOLOGICAL	Oral Formulation of Insulin	Oral formulation of insulin fed concomitantly with infant formula
BIOLOGICAL	Placebo	Oral formulation of placebo fed concomitantly with infant formula

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-08-01
• Completion: 2016-01-01
• First posted: 2010-03-26
• Last updated: 2021-03-18

Locations

1 site across 1 country: Israel