Ohki 1997.
Methods | Blinding of randomization: yes Blinding of intervention: no (nurses prepared the medication) Complete follow up: yes Blinding of outcome: yes Randomized clinical trial, cross‐over design with pooled data Washout 48 hours before the study and 48 hours at crossover | |
Participants | Number of patients entered into the study: n=8 Mechanical ventilation Entry criteria: Birthweight < 1500 g, respiratory distress requiring mechanical ventilation for > 14 days, chest radiographic evidence of chronic lung disease, no administration of diuretics for at least 48 hour before the start of the study. Exclusion criteria: evidence of congenital malformations, patent ductus arteriosus, congenital heart disease, sepsis or pneumonia. Eight infants were randomized, 6 girls and 2 boys. Average birth weight was 798±225 g and gestational age 26.5±1.9 weeks. Six of 8 patients had received surfactant for RDS. At the time of study postnatal age was 32±15 days, postconceptional age 29.3±1.5 weeks, weight 807±236 g, peak pressure 20±7 cm H2O, ventilatory rate 20±7, FiO2 0.30±0.08, paO2 65.0±13.2 mm Hg and paCO2 50.5±4.5 mm Hg. | |
Interventions | Aerosolized furosemide versus placebo Patients were randomly allocated to receive either a single dose of aerosolized furosemide 2 mg/kg diluted in 3 ml of normal saline, followed after 48 hours by placebo, or vice versa. | |
Outcomes | Main outcome: static compliance, resistance and tidal volume.
Furosemide administration was followed by a significant increase in compliance from 0.77±0.22 ml/cm/kg initially to 0.94±0.24 ml/m/kg after 1 hour and 0.92±0.18 after 2 hours; compliance did not change after placebo (corresponding values, 0.86±0.21 ml/cm/kg, 0.84±0.16 and 0.85±0.20 ml/cm/kg). Furosemide was also followed by an increase in tidal volume from 7.51±1.26 ml/kg to 9.71±1.70 after 1 hour and 9.59±2.05 after 2 hours. Tidal volume did not change after placebo (corresponding values, 8.71±1.83, 8.70±1.88 and 8.50±1.63). Neither furosemide nor placebo induced any change in resistance; baseline value in the furosemide group was 276.2±96.7 cm H2O/L/sec, and that for the control group was 250.8±95.0 cm H2O/L/sec. Secondary outcomes: urine output, serum electrolytes |
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Notes | Nebulization was done using an ultrasonic nebulizer placed in the inspiratory limb of the ventilator circuit. Pulmonary mechanics were measured at baseline and at 1 and 2 hours after aerosol administration. The authors measured static pulmonary mechanics using the passive occlusion technique. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Blinding of randomization: yes |
Allocation concealment? | Low risk | Blinding of randomization: yes |
Blinding? All outcomes | High risk | Blinding of intervention: no (nurses prepared the medication) Blinding of outcome: yes |
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 48 hours before the study and 48 hours at crossover |