Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis

Randomization and Blinding:

Subjects will be randomly assigned by a 1:1 ratio to either furosemide or placebo. The Biostatistics Unit will develop a randomization procedure using a permuted block design. The randomization will be stratified by mode of delivery of furosemide: IV or PO. Blinding will be maintained at all times throughout the study. The only unblinded study personnel will be the pharmacy department who will dispense either of placebo or furosemide to each patient. Blinding will be broken only in the case of allergic reaction in which case a pediatric attending physician, not involved with the study (designated prior to study initiation) will be notified to access the intervention of that patient. If such an event should occur, the primary investigator and IRB will be notified by e-mail/phone, and an adverse event will be documented.

Materials / Methods:

All patients aged 0-4 years old with primary diagnosis of bronchiolitis on assessment by the Emergency Department will be evaluated for inclusion to study. The goal patient enrollment is 100 patients, which is required to achieve statistical significance (see below). As this study focuses on moderate (admitted) to severe (requiring mechanical ventilation) patients with bronchiolitis, further documentation would be completed on a data collection sheet. Randomization will occur upon consent to study. In collaboration with the Biostatistics Unit, patients will be randomly assigned by a 1:1 ratio to either furosemide or placebo. There will be a randomization procedure using a permuted block design. The randomization will be stratified by mode of delivery of intervention: IV or PO. The corresponding intervention (placebo or furosemide) will then be dispensed by pharmacy for administration in a blinded manner by the patient's nurse and/or physician. Either a single dose furosemide (1mg/kg or 10mg - whichever is less) will be administered orally PO (or intravenously [IV] if IV is present), or a placebo of equal volume. Ideally, the intervention dose will be administered as early as possible (immediately after decision to admit was made and consent obtained). Subsequent retrieval of that data will be done by study personnel. Data recorded on the data collection sheet can include: O2 Saturation/Weight (pre-intervention and, 2 and 4 hours post-furosemide/control), Age, Gender, Prematurity (<32 weeks gestation), history of mechanical ventilation, history of wheeze / asthma, history of furosemide use, interventions prior to furosemide (racemic epinephrine, albuterol, or non-invasive ventilation), RSV / Influenza status, degree of dehydration (mild / moderate / severe), onset of symptoms prior to triage, +/- apnea, timing from initiation of visit until furosemide administration and/or non-invasive/invasive ventilator support, and reason for admission to ICU if necessary.

Considerations for all analyses: