Clinical Trial: Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official 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
Brief Summary: The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
Detailed Summary: The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
Sponsor: Nutrinia
Current Primary Outcome: Numbers of days to achieve complete enteral feeding [ Time Frame: 28 days or discharge from hosital ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of days to achieve discharge from hospital or readiness to discharge [ Time Frame: 28 days or discharge from hospital ]
- Growth velocity (g/kg/day) [ Time Frame: 28 days or discharge from hospital ]
Original Secondary Outcome:
- Number of days to achieve discharge from hospital or readiness to discharge [ Time Frame: 28 days or discharge from hospital ]
- Number of days to end gastric residuals over 2 ml [ Time Frame: 28 days or discharge from hospital ]
- Changes in growth parameters (height, weight, head circumference) [ Time Frame: 3 months ]
- number of patients reaching complete enteral feeding within 10 days from birth [ Time Frame: up to 10 days from birth ]
- number of patients reaching complete enteral feeding within 8 days from [ Time Frame: up to 8 days from birth ]
- number of patients reaching complete enteral feeding within 6 days from [ Time Frame: up to 6 days from birth ]
Information By: Nutrinia
Dates:
Date Received: July 24, 2015
Date Started: October 2016
Date Completion: November 2018
Last Updated: April 18, 2017
Last Verified: April 2017
