Pragmatic Research on Diuretic Management in Early BPD Pilot

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jun 1, 2023

Keywords

ClinConnect Summary

The PRIMED study is exploring how well a medication called furosemide (a type of diuretic) works for babies who are born prematurely and develop a lung condition known as bronchopulmonary dysplasia (BPD). This study aims to find out if we can determine whether a specific baby responds well to furosemide by switching between the medication and a placebo (a fake treatment). We want to learn how many babies show a short-term benefit from the medication, how many still need help with breathing after the study, and if parents and doctors would agree to give the baby furosemide for a longer period if it seems to help.

To be eligible for this study, babies must have been born before 28 weeks of pregnancy and be between 29 and 32 weeks old at the time of enrollment. They also need to be on breathing support and receiving enough nutrition through feeding. Babies with certain serious health issues or those currently treated with specific medications are not eligible. If your baby qualifies and joins the study, you can expect close monitoring and involvement in decisions about their care as we collect valuable information to improve treatment for BPD in the future.

Gender

ALL

Eligibility 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