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Oral Formulation of Insulin for Preterm Infants

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ClinicalTrials.gov Identifier: NCT01093638
Recruitment Status : Terminated
First Posted : March 26, 2010
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Nutrinia

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.

Condition or disease Intervention/treatment Phase
Premature Birth of Newborn Biological: Oral Formulation of Insulin Biological: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of days to achieve complete enteral feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ]

Secondary Outcome Measures :
  1. Number of gastric residual > 2 ml/kg [ Time Frame: Up to 28 days or discharge, at 3 months of age ]
  2. Number of gastric residual > 50% of previous feeding [ Time Frame: Up to 28 days or discharge and at 3 months of age ]
  3. Number of days to discharge [ Time Frame: Up to 28 days or discharge and at 3 months of age ]
  4. Weight gain [ Time Frame: Up to 28 days or discharge and at 3 months of age ]


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

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093638


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

Responsible Party: Nutrinia
ClinicalTrials.gov Identifier: NCT01093638     History of Changes
Other Study ID Numbers: CTILYAB004409LND10LaniadoH
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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