| Methods |
Blinding of randomization: yes
Blinding of intervention: yes
Complete follow up: yes, except for FiO2 (only documented in patients requiring mechanical ventilation)
Blinding of outcome: yes
Randomized clinical trial, parallel design
Washout period: 24 hours |
| Participants |
Patients entered into the study: n=30
The need for mechanical ventilation was not used as a criterion.
Entry criteria: (1) Significant lung disease defined as oxygen or ventilator support with chest radiograph compatible with BPD, and (2) need for furosemide for fluid overload management after a red blood cell transfusion.
Thirty infants were randomized, 14 to into the infusion (treatment) group and 16 into the bolus (control) group. The average birth weight was 1120±467 g in the treatment group and 1107±423 g in the control group. Average gestational age was 29±2.5 weeks in the treatment group and 29±2.7 weeks in the control group. At the time of the study, postnatal age was 21.2±13.6 days and 15.4±11.4 days, respectively, postconceptional age 32.0±3.1 and 31.2±3.2 weeks, respectively, and weight 1279±504 g and 1232±607 g, respectively. Both groups had similar incidence of need for artificial ventilation or for methlyxanthines, and similar mean %O2 (57±27% vs 49±19%), mean airway pressure (8.7±2.6 vs 6.9±1.5 cm H2O), mean arterial pressure, fluid intake (132 ml/kg/day in both groups the day before the study), urine output, and fractional excretion of sodium. |
| Interventions |
Furosemide infusion vs bolus.
Patients were randomly allocated to receive 1 single dose of furosemide either (1) by infusion, including a small bolus of 0.1 mg/kg over 2 minutes followed by a 6‐hour infusion of 0.9 mg/kg, or (2) by intravenous bolus of 1 mg/kg over 2 minutes followed by a 6‐hour infusion of placebo. |
| Outcomes |
Main outcomes: Urine output, fractional excretion of sodium, concentrations of serum electrolytes, FiO2, mean airway pressure, and arterial blood pressure. FiO2 is only provided in patients requiring artificial ventilation, i.e. patients randomized to furosemide bolus and 11 randomized to furosemide infusion.
Furosemide administration yielded an increase in urine output and fractional excretion of sodium in both groups, but no significant change in any of the other target variables. Average urine output was similar in both groups (˜3.6 and 3.5 ml/kg/hr, respectively), although urine output at 4 hr was lower in the first group (3.4±1.5 ml/kg/hr vs 6.0±2.1 ml/kg/hr, respectively). Fractional excretion of sodium after 8 hours tended to be lower in the infusion group (6.2%, SEM not provided, vs 10.5±14.2% in the control group). Both groups had similar mean arterial pressure, serum concentrations of Na, calcium and creatinine, mean airway pressure, and FiO2. |
| Notes |
Mean blood pressure and urine output were measured every other hour for 24 hours. Fractional excretion of sodium was measured 8 hours after furosemide. Mean airway pressure and FiO2 were averaged at 1‐4 hours and 4‐12 hours after furosemide.
The standard error was converted into standard deviation for this analysis. No standard error was reported for fractional excretion of sodium in the treatment group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomized clinical trial, parallel design |
| Allocation concealment (selection bias) |
Low risk |
Blinding of randomization: yes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of intervention: yes
Blinding of outcome: yes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow up: yes, except for FiO2 (only documented in patients requiring mechanical ventilation) |
