Oral Formulation of Insulin for Preterm Infants

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nutrinia
ClinicalTrials.gov Identifier:
NCT01093638
First received: March 24, 2010
Last updated: August 9, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Premature Birth of Newborn
Biological: Oral Formulation of Insulin
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Nutrinia:

Primary Outcome Measures:
  • Number of days to achieve complete enteral feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of gastric residual > 2 ml/kg [ Time Frame: Up to 28 days or discharge, at 3 months of age ] [ Designated as safety issue: No ]
  • Number of gastric residual > 50% of previous feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]
  • Number of days to discharge [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]
  • Weight gain [ Time Frame: Up to 28 days or discharge and at 3 months of age ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2010
Study Completion Date: January 2016
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with premature infant formula
Biological: Oral Formulation of Insulin
Oral formulation of insulin fed concomitantly with infant formula
Placebo Comparator: Oral Formulation of Placebo
Oral formulation of placebo fed concomitantly with premature infant formula
Biological: Placebo
Oral formulation of placebo fed concomitantly with infant formula

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.
  Eligibility

Ages Eligible for Study:   26 Weeks to 33 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Pre-term infants 26-33 weeks gestation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093638

Locations
Israel
NICU, Laniado Hospital
Natanya, Israel, 42150
Sponsors and Collaborators
Nutrinia
Investigators
Study Director: Naim Shehadeh, Prof. Rambam Health Care Campus
  More Information

Responsible Party: Nutrinia
ClinicalTrials.gov Identifier: NCT01093638     History of Changes
Other Study ID Numbers: CTILYAB004409LND10LaniadoH 
Study First Received: March 24, 2010
Last Updated: August 9, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016