Diuretic Therapy for Bronchopulmonary Dysplasia (PRIMED Trial)

Atlanta, GA

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 up to 5 years

Awards & highlights

Drug Has Already Been Approved

Pivotal 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.

See full description

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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