Last updated on January 2019

Paracetamol And Ibuprofen in Closing Patent Ductus Arteriosus

Brief description of study

The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, one center, clinical trial, with an additional open arm.

Detailed Study Description

Premature infants (born before 37 weeks gestational age) with paptent 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 therapy, are eligible to this trial.

If the parents deny the consent for randomization, they are asked for the permission to use the patient data of the child for research purposes. If this permission is given, these patients form the additional open arm of the study.

If the parents deny the consent, the patient will be treated according to the standard PDA treatment of Oulu University Hospital: three days' iv ibuprofen Pedea 5mg/ml solution infusion, dosing: 10 mg/kg + 5 mg/kg + 5 mg/kg (q24h). In case of any contraindications for ibuprofen, the treatment would be surgical ligation.

Clinical Study Identifier: NCT03648437

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Recruitment Status: Open

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