Paracetamol and ibuprofen/indomethacin in closing persistent ductus arteriosus
Phase 1
- Conditions
- Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Patent ductus arteriosus of a premature infant
- Registration Number
- EUCTR2018-000565-36-FI
- Lead Sponsor
- niversity of Oulu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> Timepoint(s) of evaluation of this end point: - after the study drug period<br> - discharge from neonatal intensive care unit<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - further ductal therapies<br> - neonatal morbidity and mortality: IVH, NEC, BPD, ROP<br> ;Timepoint(s) of evaluation of this end point: - discharge from hospital