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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

NCT03701074 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-30

Study results available
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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.

Conditions

  • Patent Ductus Arteriosus
  • Preterm Infant
  • Bronchopulmonary Dysplasia

Interventions

DRUG

Ibuprofen and acetaminophen

Intravenous ibuprofen given concomitantly with oral acetaminophen

DRUG

Ibuprofen and placebo

Intravenous ibuprofen given concomitantly with oral placebo

Sponsors & Collaborators

  • University of South Alabama

    lead OTHER

Principal Investigators

  • Fabien Eyal, MD · University of South Alabama

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2020-10-30
Completion
2020-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701074 on ClinicalTrials.gov