FIT-04 V7.0
Research type
Research Study
Full title
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
IRAS ID
227425
Contact name
Jon Dorling
Contact email
Sponsor organisation
Nutrinia Ltd.
Eudract number
2014-002624-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
The main purpose of the study is to learn more about the effects of NTRA-2112 (an oral form of drug insulin) in infants born prematurely who have intestinal malabsorption.
The digestive tract (which includes your esophagus, stomach and intestines) in many preterm infants is not fully developed. These infants are unable to absorb sufficient nutrients, which is described as intestinal malabsorption. Because of this reason, they have difficulties with feedings and are commonly dependent on parenteral nutrition.
The active ingredient in NTRA-2112 is the same type of human insulin naturally found in our bodies, same as the Insulin found in mother’s milk. The insulin in NTRA-2112 was turned into a powder that can be easily mixed into formula, breast milk, or saline so that it can be delivered to the digestive system orally or through a feeding tube. Blood sugar levels were not shown to be affected by insulin given through oral or enteral feedings. There is adequate evidence from clinical studies that oral administration of insulin in infants speeds up the development of the gastrointestinal tract, and therefore improves the ability of the intestine to absorb food.
We will measure the time until the premature infant can receive full enteral feeding as measured by 150ml/kg/day. This study will also look at the number of days to achieve discharge or readiness for discharge from the hospital.
Up to 530 infants will participate in this study across approximately 50 sites in the United States, Canada, Israel and Europe. Patients will be randomly assigned (like flipping a coin) to one of two doses of NTRA-2112 or placebo. The treatment period is 28 days or discharge from the hospital, whichever occurs first.
A study analysis of efficacy and safety will be conducted after all patients complete treatment.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0275
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion