Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05898022 · ClinicalTrials.gov registry record · Phase 4
Pragmatic Research on Diuretic Management in Early BPD Pilot
A Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT05898022 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 19 participants.
The verdict
NCT05898022, a Phase 4 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
Babies who are born prematurely often develop a chronic lung disease called bronchopulmonary dysplasia (BPD). BPD puts babies at higher risk for problems with growth and development. Diuretics, such as furosemide, are frequently used in the management of early BPD). Many clinicians use informal trials of therapy to see if a baby responds to diuretics in the short-term before starting chronic diuretic therapy. Despite frequent use of diuretics, it is unclear how many babies truly respond to therapy and if there are long-term benefits of diuretic treatment. Designing research studies to figure this out has been challenging. The Pragmatic Research on Diuretic Management in Early BPD (PRIMED) study is a feasibility pilot study to help us get information to design a larger trial of diuretic management for BPD. Key questions this study will answer include: (1) Can we use an N-of-1 trial to determine whether a particular baby responds to furosemide? In an N-of-1 trial, a baby is switched between furosemide and placebo to compare that particular infant's response on and off diuretics. It is a more rigorous approach to the informal trials of therapy that are often conducted in clinical care. We hope to learn how many babies have a short-term response to furosemide ("responders"); (2) how many babies will still be on respiratory support at the end of the N-of-1 trial? This will help us determine how many patients would be eligible to randomize to chronic diuretic therapy in the second phase of the larger trail, and (3) if a baby is identified as a short-term responder, how many parents and physicians would be willing to randomize the baby to chronic diuretics (3 months) versus placebo in the longer trial?
Interventions
- DRUG Furosemide (plus potassium chloride)
- DRUG Placebo (plus placebo electrolyte solution)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2025-12-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05898022
The ClinicalTrials.gov registry entry for NCT05898022 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Furosemide (plus potassium chloride) is the first listed.
NCT05898022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05898022 about?
NCT05898022 is a clinical study titled "Pragmatic Research on Diuretic Management in Early BPD Pilot". Babies who are born prematurely often develop a chronic lung disease called bronchopulmonary dysplasia (BPD). BPD puts babies at higher risk for problems with growth and development. Diuretics, such as furosemide, are frequently used in the management of early BPD). Many clinicians use informal tria...
What is the current status of trial NCT05898022?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2023-08-17. Estimated completion is 2025-12-12.
What interventions are being tested in trial NCT05898022?
The interventions under investigation include: Furosemide (plus potassium chloride) (DRUG), Placebo (plus placebo electrolyte solution) (DRUG).
Who is sponsoring clinical trial NCT05898022?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.