Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Collaborators: Helsinki University Central Hospital; Tartu University Hospital; Turku University Hospital
• Treatments: Acetaminophen; Ibuprofen; Indomethacin; Pharmaceutical Solutions

Criteria

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.)