Kao 1983.
Methods | Blinding of randomization: not mentioned ‐ 'random sequence' Blinding of intervention: not mentioned Complete follow up: yes Blinding of outcome: not mentioned Randomized controlled trial, cross‐over design with pooled data Washout period: 48 hours before study, 48 hours at cross‐over | |
Participants | Patients entered into the study: n=10 No mechanical ventilation Entry criteria: gestational age < 34 weeks, history of RDS (typical chest radiograph, need for >40% O2, need for CPAP or mechanical ventilation), continued requirement for mechanical ventilation and 30% FiO2 at 30 days of age, radiographic evidence of stage 3 or 4 of BPD by one month of age. Exclusion criteria: patent ductus arteriosus, mechanical ventilation. Ten patients were included into the study. Mean birth weight was 1.37±0.63 kg, gestational age 30.0±3.2 weeks, average postnatal age 11 weeks, postconceptional age 41.0±3.2 weeks and weight 2.28±0.38 kg. There was no difference between furosemide and placebo periods in baseline values of lung volume and resistance. Baseline values for compliance tended to be 27% lower during the furosemide period than during the placebo period, and those for conductance were 26 % lower (p<0.05 by unpaired Student t‐test). | |
Interventions | Furosemide vs placebo Patients were randomly allocated, either to receive 1 dose of furosemide 1 mg/kg iv followed after 48 hours by placebo (10% glucose in water), or vice versa. Fluid intake was similar on furosemide and on placebo (175.4±38.0 vs 175.5±30.4 ml/kg/day). | |
Outcomes | No changes in urine output or pulmonary function occurred versus baseline after placebo administration. Furosemide resulted in a significantly higher increase than placebo for urine output during the first period (0‐1 hr, +226±85% vs ‐9±49%, respectively, p<0.001) and the second period (1‐3 hr, +58±74% vs 0±22%, p<0.05). Furosemide administration resulted in a significantly better improvement than placebo for the following variables: compliance at 1 hour (+54±41% vs +2±5% with placebo, p<0.01), airway conductance both at 1/2 hour (+54±52% vs ‐18±6% with placebo, p<0.001) and at 1 hour (+84±70% vs +3±8% with placebo, p<0.01) and resistance at 1/2 hour (‐30±37% vs +2±3%, p<0.05) and at 1 hour (‐35±41% vs ‐5±3%, p<0.05. The authors state there was no significant change in thoracic gas volume; data are not provided. | |
Notes | Measurements of pulmonary function and urine were obtained at 1/2, 1,2,4,6 and 24 hours after medication administration. Patients were lightly sedated with chloral hydrate (5‐10 mg/kg). The authors measured airway resistance by plethysmography and dynamic compliance using an esophageal balloon. Urine output was measured over the following periods: 0‐1, 1‐3,3‐6,6‐16 and 16‐24 hours. Values are presented as % of baseline. Some values of pulmonary function measurements calculated from the figures were overridden to match those in the text. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized controlled trial, cross‐over design with pooled data Blinding of randomization: not mentioned ‐ 'random sequence' |
Allocation concealment (selection bias) | Unclear risk | Blinding of randomization: not mentioned ‐ 'random sequence' |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding of intervention: not mentioned Blinding of outcome: not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow up: yes |