NCT03648437

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus of Preterm Infants - Randomised, Placebo-controlled Multicentre Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Premature infants (born before 37 weeks gestational age) with patent ductus arteriosus (PDA) are the focus of the study since no trials on the additive efficacy of these two medications on the contraction of ductus arteriosus are available. Preterm infants who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen/indomethacin therapy, are eligible to this trial. If the parents deny the consent, the patient will be treated according to the standard PDA treatment: three days' iv ibuprofen Pedea® 5mg/ml solution infusion (Oulu, Helsinki, Tartu) dosing: 10mg/kg + 5mg/kg + 5mg/kg (q24h); or three days' iv indomethacin (Turku) 0.2mg/kg + 0.1mg/kg + 0.1mg/kg (q24h). In case of any contraindications for ibuprofen/indomethacin, the treatment would be surgical ligation.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Paracetamol 10Mg/mL	Experimental drug
DRUG	0.45% Sodium Chloride	Placebo comparator
DRUG	Ibuprofen	Standard therapy
DRUG	Indomethacin	Standard therapy

Timeline

• Start date: 2018-09-03
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2018-08-27
• Last updated: 2024-10-18

Locations

4 sites across 1 country: Finland