Pragmatic Research on Diuretic Management in Early BPD Pilot (PRIMED)
Bronchopulmonary Dysplasia
About this trial
This is an interventional other trial for Bronchopulmonary Dysplasia focused on measuring furosemide, ventilator-induced lung injury, lung injury, lung diseases, respiratory tract diseases, infant, premature diseases, newborn, diseases, diuretics
Eligibility Criteria
Inclusion Criteria: <28 weeks gestation at birth Post-Menstrual Age (PMA) of 30-32 weeks gestation Requiring positive pressure respiratory support (NCPAP≥ 5 cm H20, NIPPV/BiPhasic CPAP, or mechanical ventilation) Receiving FiO2 ≥ 30% Receiving enteral feedings of 120 mL/kg/day or greater Expected to be hospitalized for at least 28 days after enrollment Exclusion Criteria: Major congenital anomalies (e.g., known renal anomalies, congenital heart disease, congenital diaphragmatic hernia, or chromosomal anomalies) Serum creatinine > 1.7 mg/dL, BUN >50 mg/dL, Na <125 mmoL/L, K ≤ 2.5 mmol/L, or Ca ≤ 6 mg/dL in week prior to enrollment Treatment with a time-limited course of Dexamethasone or hydrocortisone within 10 days of enrollment. Exposure to a time-limited course dexamethasone or hydrocortisone for respiratory failure within 10 days of enrollment may result in carryover effects that confound the N-of-1 trial. Treatment with chronic steroids for adrenal insufficiency is not an exclusion criteria. Treatment with any diuretics within 7 days of enrollment. Exposure to diuretics within 7 days of enrollment may result in carryover effects that confound the N-of-1 trial. Non-English speaking
Sites / Locations
- Emory University
- RTI International
- Cincinnati Children's Hospital Medical CenterRecruiting
- Case Western Reserve University, Rainbow Babies and Children's HospitalRecruiting
Arms of the Study
Arm 1
Other
N-of-1 Trial
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.