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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: All
• Age: 5 Days – 21 Days
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of the study are to confirm the safety of oral acetaminophen in extremely low birth infants, given concomitantly with intravenous ibuprofen and also to determine its efficacy in significantly increasing the rates of ductal closure when compared to only intravenous ibuprofen therapy. Hence primary outcome variable include patent ductus arteriosus closure success rate, based on the 2-D transthoracic echocardiographic evidence. This study is a single center, randomized, double blinded, placebo controlled trial. Preterm infants with gestational age of with a gestational age ≤27 6/7 weeks by the best obstetric estimate are eligible for enrollment. For randomization, the study population will be stratified to two subgroups based on gestational age (GA ≤24 weeks and \> 25 weeks). Randomization will occur by using computer generated random sequence, using a 4-block design, with 1:1 parallel allocation. Allocations include treatment and control arm. Treatment arm will receive combination of intravenous ibuprofen and oral acetaminophen, while control arm will receive intravenous Ibuprofen and oral placebo.

Conditions

• Patent Ductus Arteriosus
• Preterm Infant
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Ibuprofen and acetaminophen	Intravenous ibuprofen given concomitantly with oral acetaminophen
DRUG	Ibuprofen and placebo	Intravenous ibuprofen given concomitantly with oral placebo

Timeline

• Start date: 2018-12-15
• Primary completion: 2020-10-30
• Completion: 2020-12-02
• First posted: 2018-10-09
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study