Premature Birth of Newborn
Conditions
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.
Interventions
BIOLOGICALOral Formulation of Insulin
Oral formulation of insulin fed concomitantly with infant formula
BIOLOGICALPlacebo
Oral formulation of placebo fed concomitantly with infant formula
Sponsors
Elgan Pharma Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 33 Weeks
Healthy volunteers
Yes
Inclusion criteria
1\. Pre-term infants 26-33 weeks gestation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days to achieve complete enteral feeding | Up to 28 days or discharge and at 3 months of age |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of days to discharge | 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 |
Countries
Israel
Outcome results
None listed