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NCT03701074 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by University of South Alabama.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03701074: Clinical Trial Phase 2 study, sponsored by University of South Alabama.
NCT03701074 is a Phase 2 study that was terminated before completion, run by University of South Alabama. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701074, a Phase 2 study, was terminated before completion, sponsored by University of South Alabama.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter \<1 mm
Interventions
- DRUG Ibuprofen and acetaminophen
- DRUG Ibuprofen and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-12-15 |
| Est. Completion | 2020-12-02 |
| Phase | Phase 2 |
Why NCT03701074 stopped before completion
NCT03701074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen and acetaminophen is the first listed.
NCT03701074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03701074 about?
NCT03701074 is a clinical study titled "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". 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 intr...
What is the current status of trial NCT03701074?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2018-12-15. Estimated completion is 2020-12-02.
What interventions are being tested in trial NCT03701074?
The interventions under investigation include: Ibuprofen and acetaminophen (DRUG), Ibuprofen and placebo (DRUG).
Who is sponsoring clinical trial NCT03701074?
This trial is sponsored by University of South Alabama, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03701074's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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