NCT01093638

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

March 24, 2010

Last Update Submit

March 16, 2021

Conditions

Premature Birth of Newborn

Outcome Measures

Primary Outcomes (1)

  • Number of days to achieve complete enteral feeding

    Up to 28 days or discharge and at 3 months of age

Secondary Outcomes (4)

  • 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

Study Arms (2)

Oral Formulation of Insulin

EXPERIMENTAL

Oral formulation of insulin fed concomitantly with premature infant formula

Biological: Oral Formulation of Insulin

Oral Formulation of Placebo

PLACEBO COMPARATOR

Oral formulation of placebo fed concomitantly with premature infant formula

Biological: Placebo

Interventions

Oral Formulation of InsulinBIOLOGICAL

Oral formulation of insulin fed concomitantly with infant formula

Oral Formulation of Insulin
PlaceboBIOLOGICAL

Oral formulation of placebo fed concomitantly with infant formula

Oral Formulation of Placebo

Eligibility Criteria

Age26 Weeks - 33 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. Pre-term infants 26-33 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU, Laniado Hospital

Netanya, 4244916, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Naim Shehadeh, Prof.

    Rambam Health Care Campus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 26, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

January 1, 2016

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)