drugset / Trial / NCT03648437
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
Phase 1
Terminated
22 enrolled
University of Oulu
Helsinki University Central Hospital · collabTampere University Hospital · collabTurku University Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.
Timeline
- Start
- 2018-09-03
- Primary completion
- 2024-10-04
- Completion
- 2024-10-04
Outcome
Outcome not reported
Stopped (Enrollment): “The PDA patients have vanished. The last recruitment took place in 2022. In the joint discussion of the principal researchers, it was concluded that PDA patients no longer have to be treated in Finland and the study was terminated.”
Publications
- Background Harkin P, Harma A, Aikio O, Valkama M, Leskinen M, Saarela T, Hallman M. Paracetamol Accelerates Closure of the Ductus Arteriosus after Premature Birth: A Randomized Trial. J Pediatr. 2016 Oct;177:72-77.e2. doi: 10.1016/j.jpeds.2016.04.066. Epub 2016 May 20.
- Background Juujarvi S, Saarela T, Hallman M, Aikio O. Intravenous paracetamol was associated with closure of the ductus arteriosus in extremely premature infants. Acta Paediatr. 2018 Apr;107(4):605-610. doi: 10.1111/apa.14137. Epub 2017 Nov 17.
- Background Harma A, Aikio O, Hallman M, Saarela T. Intravenous Paracetamol Decreases Requirements of Morphine in Very Preterm Infants. J Pediatr. 2016 Jan;168:36-40. doi: 10.1016/j.jpeds.2015.08.003. Epub 2015 Aug 29.
- Background Aikio O, Harkin P, Saarela T, Hallman M. Early paracetamol treatment associated with lowered risk of persistent ductus arteriosus in very preterm infants. J Matern Fetal Neonatal Med. 2014 Aug;27(12):1252-6. doi: 10.3109/14767058.2013.854327. Epub 2013 Oct 31.
- Background Juujarvi S, Kallankari H, Patsi P, Leskinen M, Saarela T, Hallman M, Aikio O. Follow-up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two-years corrected age. Acta Paediatr. 2019 Mar;108(3):452-458. doi: 10.1111/apa.14614. Epub 2018 Nov 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 7.5 mg/kg | Intravenous |
| Background | Ibuprofen | Small molecule | 5 mg/kg | Intravenous |
| Background | Indomethacin | Small molecule | 0.1 mg/kg | — |