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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
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
Ibuprofen and acetaminophen
Intravenous ibuprofen given concomitantly with oral acetaminophen
Ibuprofen and placebo
Intravenous ibuprofen given concomitantly with oral placebo
Locations (1)
University of South Alabama
Mobile, Alabama, United States