| Methods |
Blinding of randomization: not documented
Blinding of intervention: not documented
Complete follow up: yes
Blinding of outcome: not documented
Randomized clinical trial, cross‐over design with pooled data
Washout period: bronchodilators 4 hr before study; no diuretics or glucocorticosteroids used before study in any patient |
| Participants |
Number of patients entered into the study: n=13
Mechanical ventilation
Entry criteria: Prematurity, requirement of oxygen and mechanical ventilation for primary lung disease for at least 14 days
Exclusion criteria: major congenital anomalies
Mean birth weight was 713±132 g, gestational age 25.4±1.5 weeks, postnatal age 24±9.5 days and postconceptional age 28.8±2.0 weeks. Baseline values of compliance, tidal volume, resistance and urine output before the 2 mg/kg dose were similar to those before the 1 mg/kg dose. |
| Interventions |
Aerosolized furosemide 2 mg/kg vs 1 mg/kg
Patients were randomized to receive either aerosolized furosemide 1 mg/kg once, followed by a 2 mg/kg dose after 24 hours, or vice versa. |
| Outcomes |
Main outcome: magnitude and duration (beyond 2 hours) of the effects of furosemide on pulmonary mechanics.
Secondary outcome:urine output and urinary excretion of electrolytes.
Repeated measures ANOVA showed that both doses significantly increased compliance and tidal volume for up to 6 hours. The 2 doses of furosemide yielded non significantly different values of compliance and tidal volume at 2, 4 and 6 hours.
Furosemide administration was not followed by any significant change in urinary output or urinary electrolyte excretion after either dose of furosemide. |
| Notes |
Furosemide was nebulized via the inspiratory limb of the ventilator circuit, using a flow of 2 L/min and a nebulizer (MiniHeart, Vortran Medical Technology).
Pulmonary function tests were obtained at baseline and at 2,4 and 6 hours after administration of the aerosol. Pulmonary mechanics were measured using the two‐factor, least mean square technique without an esophageal balloon. Urine was collected for six hours before and six hours after aerosol administration.
Theophylline was continued in those infants already on this medication before the study; no infant was started on theophylline during the 2‐day study period. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Blinding of randomization: not documented |
| Allocation concealment? |
Unclear risk |
Blinding of randomization: not documented |
| Blinding?
All outcomes |
Unclear risk |
Blinding of intervention: not documented
Blinding of outcome: not documented |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Complete follow‐up: yes |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Unclear risk |
Randomized clinical trial, cross‐over design with pooled data
Washout period: bronchodilators 4 hr before study; no diuretics or glucocorticosteroids used before study in any patient |
