A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Elgan Pharma Ltd.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Number of days to achieve complete enteral feeding
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 26 Weeks to 33 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pre-term infants 26-33 weeks gestation.
Exclusion Criteria
- Not provided
Arms & Interventions
Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with premature infant formula
Intervention: Oral Formulation of Insulin (Biological)
Oral Formulation of Placebo
Oral formulation of placebo fed concomitantly with premature infant formula
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Number of days to achieve complete enteral feeding
Time Frame: Up to 28 days or discharge and at 3 months of age
Secondary Outcomes
- Number of days to discharge(Up to 28 days or discharge and at 3 months of age)
- Number of gastric residual > 2 ml/kg(Up to 28 days or discharge, 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)