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TERMINATED
NCT03701074
PHASE2

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

Sponsor: University of South Alabama

View on ClinicalTrials.gov

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.

Official title: Single Center, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

Key Details

Gender

All

Age Range

5 Days - 21 Days

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2018-12-15

Completion Date

2020-12-02

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

Ibuprofen and acetaminophen

Intravenous ibuprofen given concomitantly with oral acetaminophen

DRUG

Ibuprofen and placebo

Intravenous ibuprofen given concomitantly with oral placebo

Locations (1)

University of South Alabama

Mobile, Alabama, United States