Therapy of patency of ductus arteriosus (PDA) in very low birth weight (VLBW)preterm infants: oral ibuprofen versus intravenous ibuprofen - NEO 12
- Conditions
- treatment on pharmacological closure of patent ductus arteriosus (PDA)in preterm very low birthweight infants.MedDRA version: 9.1Level: HLGTClassification code 10028920
- Registration Number
- EUCTR2010-018771-23-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA S. CROCE E CARLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Gestational age ≤ 32 weeks and/or weight < 1500 g Respiratory distress with O2 request > 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
Left to right Shunt Congenital Heart Diseases with ductal dependency Intraventricular Hemorrage (3-4degree) Bleeding symptoms Gastrintenstinal symptoms Mayor congenital malformations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method