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Loop Diuretic

Diuretic Therapy for Bronchopulmonary Dysplasia (PRIMED Trial)

Phase 4
Recruiting
Led By Heather Kaplan, MD, MSCE
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

PRIMED Trial Summary

This trial is researching if diuretics help premature babies with BPD, if they have short-term & long-term benefits, & if parents & docs are willing to randomize.

Who is the study for?
This trial is for premature babies with a lung condition called bronchopulmonary dysplasia (BPD), who are expected to be hospitalized for at least 28 days, can eat enough, need extra oxygen, and were born before the 28th week of pregnancy. Babies on certain steroids or diuretics recently, those with specific blood test results or major birth defects aren't eligible.Check my eligibility
What is being tested?
The PRIMED study tests if furosemide helps babies with BPD by comparing it against a placebo in an N-of-1 trial design. This means each baby will receive both the real medicine and a fake one at different times to see which works better for them individually.See study design
What are the potential side effects?
Furosemide may cause dehydration, electrolyte imbalances like low potassium (which is why potassium chloride is also given), kidney issues, and hearing problems. The exact side effects in these very young patients will be closely monitored.

PRIMED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of enrolled infants who completed the full N-of-1 trial, remain on respiratory support at the conclusion of the N-of-1 trial, and were identified as a responder
Percent of providers willing to support randomizing a responder infant
Secondary outcome measures
Percent of enrolled infants completing full N-of-1 trial
Percent of enrolled infants completing full N-of-1 trial and identified as responder
Percent of enrolled infants on respiratory support at the conclusion of the N-of-1 trial
+2 more

PRIMED Trial Design

1Treatment groups
Experimental Treatment
Group I: N-of-1 TrialExperimental Treatment2 Interventions
Each individual N-of-1 trial will have 2 blocks. In each block patients will crossover between furosemide (plus potassium chloride) for 1 week and placebo (plus placebo electrolyte solution) for 1 week. The total arm length (length of the N-of-1 Trial/Crossover) is 28 days. Patients may receive furosemide (plus potassium chloride) and placebo (plus placebo electrolyte solution) in one of four different treatment order sequences, however, treatment order will not be analyzed for the primary outcomes of feasibility/responder status.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,561 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
169 Patients Enrolled for Bronchopulmonary Dysplasia
Rainbow Babies and Children's HospitalOTHER
8 Previous Clinical Trials
3,923 Total Patients Enrolled
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,627 Total Patients Enrolled

Media Library

Furosemide (Loop Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05898022 — Phase 4
Bronchopulmonary Dysplasia Research Study Groups: N-of-1 Trial
Bronchopulmonary Dysplasia Clinical Trial 2023: Furosemide Highlights & Side Effects. Trial Name: NCT05898022 — Phase 4
Furosemide (Loop Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05898022 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other healthcare facilities in this urban area where the clinical trial is taking place?

"The current medical trial is hosted across 4 sites, including locations in Atlanta, Cincinnati and Cleveland. Patients should consider the proximity of a centre to lessen travel burden when selecting their preferred location."

Answered by AI

Has regulatory approval been granted for this therapeutic intervention?

"Power's estimation of the treatment's safety is a 3, as this procedure has reached Phase 4 and thus been given regulatory approval."

Answered by AI

Am I eligible to join this research project?

"To qualify for this research project, the patient must have bronchopulmonary dysplasia and be within a 2 to 10 week old age range. 30 individuals are expected to join this trial."

Answered by AI

Is this research study actively recruiting participants?

"The research listed on clinicaltrials.gov is no longer recruiting participants. This trial was initially made public on July 1st 2023 and its data was last modified one month ago. Although this particular study has concluded recruitment, there are 55 other medical trials open to new patients at present."

Answered by AI

Does the study accept those over seventy-five years of age?

"This medical research explicitly states that participants must fall between the age of 14 days and 70 days to be considered eligible."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pragmatic Research on Diuretic Management in Early BPD Pilot
Heather Kaplan 2023. "Pragmatic Research on Diuretic Management in Early BPD Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05898022.
~20 spots leftby Sep 2025
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