TerminatedPhase 1

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

Stopped: 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.

Finland22 participantsStarted 2018-09-03

Plain-language 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.

Who can participate

Age range4 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen therapy, are eligible to this trial. Exclusion Criteria: * severe malformation or suspected chromosomal defect * other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)

What they're measuring

Ductal closure

Timeframe: Neonatal internsive care unit (NICU) stay up to 12 weeks

Trial details

NCT IDNCT03648437

SponsorUniversity of Oulu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-04

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials