Research on diuretic management for premature babies with lung disease
Pragmatic Research on Diuretic Management in Early Bronchopulmonary Dysplasia (PRIMED) Pilot Study
This study is testing if a diuretic called furosemide can help premature babies with lung disease feel better by seeing how they respond to the medication compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Weeks to 10 Weeks |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT05898022 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of diuretics, specifically furosemide, in managing bronchopulmonary dysplasia (BPD) in premature infants. It aims to determine if an N-of-1 trial approach can effectively assess individual responses to furosemide treatment. The study will involve switching infants between furosemide and placebo to evaluate short-term responses before considering long-term diuretic therapy. The findings will inform the design of a larger trial focused on diuretic management for BPD.
Who should consider this trial
Good fit: Ideal candidates are infants born before 28 weeks of gestation who require respiratory support and are expected to be hospitalized for at least 28 days.
Not a fit: Patients with major congenital anomalies or those currently receiving specific steroid treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for premature infants suffering from bronchopulmonary dysplasia.
How similar studies have performed: While the use of diuretics in BPD management is common, this specific N-of-1 trial approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \<28 weeks gestation at birth 2. Post-Menstrual Age (PMA) of 29-32 weeks gestation 3. Requiring invasive positive pressure respiratory support or NIPPV/NIMV and FiO2 ≥ 25% or requiring non-invasive positive pressure respiratory support (NCPAP≥ 5 cm H20, BiPhasic CPAP) and FiO2 ≥ 30%. 4. Receiving enteral feedings of 120 mL/kg/day or greater 5. Expected to be hospitalized for at least 28 days after enrollment Exclusion Criteria: 1. Major congenital anomalies (e.g., known renal anomalies, congenital heart disease, congenital diaphragmatic hernia, or chromosomal anomalies) 2. In infants who had electrolyte testing in the week prior to enrollment, those with a serum creatinine \> 1.7 mg/dL, BUN \>50 mg/dL, Na \<125 mmoL/L, K ≤ 2.5 mmol/L, or Ca ≤ 6 mg/dL. Not having electrolyte testing in the week prior to enrollment is not an exclusion criterion. 3. Current treatment with Dexamethasone or hydrocortisone for respiratory failure. Treatment with chronic steroids for history of adrenal insufficiency or cardiovascular instability is not an exclusion criterion. 4. Treatment with any longer-acting diuretic (e.g., chlorothiazide, hydrochlorothiazide, acetazolamide) within 5 days of enrollment where exposure may result in carryover effects that confound the N-of-1 trial 5. Active order for standing, regularly scheduled diuretics (e.g., chronic diuretics) 6. Non-English speaking 7. Current treatment with ibuprofen or indocin
Where this trial is running
Atlanta, Georgia and 3 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- RTI International — Durham, North Carolina, United States (Active_not_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Heather Kaplan, MD, MSCE — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Heather Kaplan, MD, MSCE
- Email: heather.kaplan@cchmc.org
- Phone: 513-803-0478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.