Impact of oral application of Gastrografin on the meconium evacuation in very low birth weight infants

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Gastrografin Product Name: Gastrografin Product Code: Gastrografin Pharmaceutical Form: Gastroenteral suspension INN or Proposed INN: Gastrografin Pharmaceutical form of the placebo: Gastroenteral solution Route of administration of the placebo: Enteral use (Noncurrent) CONDITION: Evacuation of inspissated meconium in very low birth weight infants (infants with a birthweight below 1500 grams) PRIMARY OUTCOME: Main Objective: accelerate meconium evacuation in very low birth weight infants Primary end point(s): time to appearence of last meconium in days Secondary Objective: impact of the procedure on introduction of enteral feedings‐ ; shorter time on full enteral feedings INCLUSION CRITERIA: inborn very low birth weight infants with abirthweight below 1500 grams and a gestational age below 32 weeks Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: a073e2f43a7e965642a19c665d09c842f1c38604
First added on: Aug 21, 2024