Oral Formulation of Insulin for Preterm Infants

Premature Birth of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01093638
• Other study ID #: CTILYAB004409LND10LaniadoH
• Status: Terminated
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: January 2016

Study information

• Verified date: March 2021
• Source: Elgan Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Intervention

Biological:
• Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with infant formula
• Placebo
Oral formulation of placebo fed concomitantly with infant formula

Locations

Country	Name	City	State
Israel	NICU, Laniado Hospital	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Elgan Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to achieve complete enteral feeding		Up to 28 days or discharge and at 3 months of age
Secondary	Number of gastric residual > 2 ml/kg		Up to 28 days or discharge, at 3 months of age
Secondary	Number of gastric residual > 50% of previous feeding		Up to 28 days or discharge and at 3 months of age
Secondary	Number of days to discharge		Up to 28 days or discharge and at 3 months of age
Secondary	Weight gain		Up to 28 days or discharge and at 3 months of age