Oral Formulation of Insulin for Preterm Infants

March 16, 2021 updated by: Elgan Pharma Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel, 4244916
        • NICU, Laniado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with premature infant formula
Biological: Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with infant formula
Placebo Comparator: Oral Formulation of Placebo
Oral formulation of placebo fed concomitantly with premature infant formula
Biological: Placebo
Oral formulation of placebo fed concomitantly with infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days to achieve complete enteral feeding
Time Frame: Up to 28 days or discharge and at 3 months of age
Up to 28 days or discharge and at 3 months of age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elgan Pharma Ltd.

Investigators

  • Study Director: Naim Shehadeh, Prof., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTILYAB004409LND10LaniadoH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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