Back to resultsOral Formulation of Insulin for Preterm Infants
Primary Purpose
Premature Birth of Newborn
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Oral Formulation of Insulin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth of Newborn
Eligibility Criteria
Inclusion Criteria:
1. Pre-term infants 26-33 weeks gestation.
Sites / Locations
- NICU, Laniado Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral Formulation of Insulin
Oral Formulation of Placebo
Arm Description
Oral formulation of insulin fed concomitantly with premature infant formula
Oral formulation of placebo fed concomitantly with premature infant formula
Outcomes
Primary Outcome Measures
Number of days to achieve complete enteral feeding
Secondary Outcome Measures
Number of gastric residual > 2 ml/kg
Number of gastric residual > 50% of previous feeding
Number of days to discharge
Weight gain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093638
Brief Title
Oral Formulation of Insulin for Preterm Infants
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elgan Pharma Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Formulation of Insulin
Arm Type
Experimental
Arm Description
Oral formulation of insulin fed concomitantly with premature infant formula
Arm Title
Oral Formulation of Placebo
Arm Type
Placebo Comparator
Arm Description
Oral formulation of placebo fed concomitantly with premature infant formula
Intervention Type
Biological
Intervention Name(s)
Oral Formulation of Insulin
Intervention Description
Oral formulation of insulin fed concomitantly with infant formula
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Oral formulation of placebo fed concomitantly with infant formula
Primary Outcome Measure Information:
Title
Number of days to achieve complete enteral feeding
Time Frame
Up to 28 days or discharge and at 3 months of age
Secondary Outcome Measure Information:
Title
Number of gastric residual > 2 ml/kg
Time Frame
Up to 28 days or discharge, at 3 months of age
Title
Number of gastric residual > 50% of previous feeding
Time Frame
Up to 28 days or discharge and at 3 months of age
Title
Number of days to discharge
Time Frame
Up to 28 days or discharge and at 3 months of age
Title
Weight gain
Time Frame
Up to 28 days or discharge and at 3 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Pre-term infants 26-33 weeks gestation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naim Shehadeh, Prof.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
Facility Information:
Facility Name
NICU, Laniado Hospital
City
Netanya
ZIP/Postal Code
4244916
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Formulation of Insulin for Preterm Infants
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