Patent ductus arteriosus of a premature infant
Conditions
Interventions
Product Name: Paracetamol Kabi Pharmacia 10 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg/ml milligram(s
Sponsors
University of Oulu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - premature infants - treated in the neonatal intensive care units of the attending sites - diagnosed to have a hemodynamically significant patent ductus arteriosus - intravenous ibuprofen or indomethacin medication Are the trial subjects under 18? yes Number of subjects for this age range: 60 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: - no parental consent - any congenital or chromosomal anomaly or severe clinical situation that complicates the conventional ductal therapy, e.g. severe asphyxia or persistent pulmonary hypertension of a newborn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect and safety of intravenous paracetamol when combining with ibuprofen/indomethacin therapy for patent ductus arteriosus;Secondary Objective: Not applicapple;Primary end point(s): Ductal closure;Timepoint(s) of evaluation of this end point: - after the study drug period - discharge from neonatal intensive care unit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - further ductal therapies - neonatal morbidity and mortality: IVH, NEC, BPD, ROP;Timepoint(s) of evaluation of this end point: - discharge from hospital | — |
Countries
Estonia, Finland
Contacts
Public ContactDepartment of Pediatrics
Oulu University Hospital
Outcome results
None listed