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NCT03103022 · ClinicalTrials.gov registry record · Phase 1
Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03103022: Completed Phase 1 study, sponsored by University of Florida.
NCT03103022 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03103022, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause problems such as bleeding in the lung and brain, lung injury due to prolonged need of ventilator, and poor kidney function. It sometimes becomes necessary to close this blood vessel in the preterm infant. Currently, this blood vessel can be closed either by medication or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used medications to close PDA. However, in the last 5 year, acetaminophen has been found as an alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is found to be a safe alternative medication with lower side effects than current standard management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants. Although not approved by FDA, oral ibuprofen is being used for the management of PDA. However, the success rate of a single medication is approximately 70%. Both medications have been used in the previous clinical studies to treat the same condition in the preterm infants and fewer side effects were reported. Mechanism of both medications to close PDA is different and may work more effectively together than single medication alone. In this study, the investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same time if the child needs treatment and is eligible to participate in this study. This study is based on the assumption that by using both medications at the same time, investigator can close this blood vessel more effectively than with either drug alone.
Primary Outcome
To determine the ductal closure rate on echocardiography after completion of a first treatment course.
Interventions
- DRUG Acetaminophen
- DRUG ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 1 |
What the finished NCT03103022 record still lists
NCT03103022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT03103022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03103022 about?
NCT03103022 is a clinical study titled "Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus". Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause problems such as bleeding...
What is the current status of trial NCT03103022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-06-12. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03103022?
The interventions under investigation include: Acetaminophen (DRUG), ibuprofen (DRUG).
Who is sponsoring clinical trial NCT03103022?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03103022's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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