drugset / Trial / NCT02602054

The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants

NCT02602054

RandomizedParallel-groupOpen-labelTreatment

Summary

The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision. This study aims to determine the efficacy and safety of surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.

Timeline

Start
2015-10
Primary completion
2016-04
Completion
2017-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 15 mg/kg
Comparator Ibuprofen Small molecule 5 mg/kg
Comparator Ibuprofen Small molecule 10 mg/kg
Comparator Indomethacin Small molecule 0.1 mg/kg
Comparator Indomethacin Small molecule 0.2 mg/kg
Comparator Indomethacin Small molecule 0.25 mg/kg