Trial | NCT01093638  Report issue

Title

Oral Formulation of Insulin for Preterm Infants
A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    insulin human ...

  • Study Participants

    33
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.
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 Started
Aug 31
2010
Primary Completion
Aug 31
2013
Study Completion
Jan 31
2016
Last Update
Mar 18
2021

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

Oral Formulation of Insulin Experimental

Oral formulation of insulin fed concomitantly with premature infant formula

Oral Formulation of Placebo Placebo Comparator

Oral formulation of placebo fed concomitantly with premature infant formula

Criteria 

Inclusion Criteria:

1. Pre-term infants 26-33 weeks gestation.
No Results Posted