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Oral Formulation of Insulin for Preterm Infants

NCT01093638 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-03-18

No results posted yet for this study

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.

Conditions

  • Premature Birth of Newborn

Interventions

BIOLOGICAL

Oral Formulation of Insulin

Oral formulation of insulin fed concomitantly with infant formula

BIOLOGICAL

Placebo

Oral formulation of placebo fed concomitantly with infant formula

Sponsors & Collaborators

  • Elgan Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Naim Shehadeh, Prof. · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2016-01-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093638 on ClinicalTrials.gov