treatment on pharmacological closure of patent ductus arteriosus (PDA)in preterm very low birthweight infants. MedDRA version: 9.1 Level: HLGT Classification code 10028920
Conditions
Interventions
Trade Name: ANTALFEBAL
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Ibuprofen
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade
Sponsors
AZIENDA OSPEDALIERA "S. CROCE E CARLE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gestational age ≤ 32 weeks and/or weight 25% Indication to the PDA closure (echocardiogram) 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
Exclusion criteria
Exclusion criteria: Left to right Shunt Congenital Heart Diseases with ductal dependency Intraventricular Hemorrage (3-4degree) Bleeding symptoms Gastrintenstinal symptoms Mayor congenital malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of efficacy and tolerance between oral and intravenous ibuprofen on closure of patent ductus arteriosus (PDA) in preterm very low birthweight infants.;Secondary Objective: Incidence of: PDA reopening, bronchopulmonary dysplasia at 36 weeks gestational age, gastrointestinal bleeding, focal intestinal perforation, necrotizing enterocholitis (NEC) duration of mechanical ventilation, lenght of stay in Neonatal Intensive Care Unit;Primary end point(s): Equivalent efficacy of oral ad intravenous ibuprofen | — |
Countries
Italy
Outcome results
None listed