The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Numbers of Days to Achieve Complete Enteral Feeding
Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
Time frame: 28 days or discharge from hospital
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
Readiness for discharge from hospital is defined as achieving all of the below: * Infant weight ≥ 1800g * Stable body temperature * Capable of oral feeding (reached full enteral feeding and not dependent on PN)
Time frame: 28 days or discharge from hospital
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vidant Medical Center
Greenville, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
AZ Sint-Jan
Bruges, Belgium
UZ Brussel
Brussels, Belgium
CHR de la Citadelle
Liège, Belgium
CHC Cliniques Saint-Vincent
Rocourt, Belgium
GZA Sint-Augustinus
Wilrijk, Belgium
CHRU Nancy, Maternité Régionale
Nancy, France
...and 40 more locations