drugset / Trial / NCT03701074
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.
Timeline
- Start
- 2018-12-15
- Primary completion
- 2020-10-30
- Completion
- 2020-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Background | Ibuprofen | Small molecule | 9 mg/kg | Intravenous |