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Oral Formulation of Insulin for Preterm Infants

NCT ID: NCT01093638

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Premature Birth of Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral Formulation of Insulin

Oral formulation of insulin fed concomitantly with premature infant formula

Group Type EXPERIMENTAL

Oral Formulation of Insulin

Intervention Type BIOLOGICAL

Oral formulation of insulin fed concomitantly with infant formula

Oral Formulation of Placebo

Oral formulation of placebo fed concomitantly with premature infant formula

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Oral formulation of placebo fed concomitantly with infant formula

Interventions

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Oral Formulation of Insulin

Oral formulation of insulin fed concomitantly with infant formula

Intervention Type BIOLOGICAL

Placebo

Oral formulation of placebo fed concomitantly with infant formula

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1\. Pre-term infants 26-33 weeks gestation.
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elgan Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naim Shehadeh, Prof.

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Locations

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NICU, Laniado Hospital

Netanya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CTILYAB004409LND10LaniadoH

Identifier Type: -

Identifier Source: org_study_id

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