| Methods |
Blinding of randomization: unclear: All investigators but one were blinded. The role of this investigator in the study and in patient care is not clearly stated.
Blinding of intervention: unclear (see above).
Complete follow‐up: no: 43 out of 49 patients completed the study. Six were eliminated, three in each group, including 5 at the request of the parents and 1 because parents moved out of state.
Blinding of outcome: unclear (see above).
Randomized trial, parallel design.
Washout period: 3‐5 days before the study |
| Participants |
Patients entered into the study: n=49
No mechanical ventilation.
Entry criteria: typical radiographic appearance of Northway stage II or IV BPD, history of mechanical ventilatory support for > 1 month, stability after extubation for > week, weight > 1.5 kg, fractional excretion of O2 (FiO2) 0.30‐0.50.
Exclusion criteria: rib cage deformities, congenital heart disease, chromosomal abnormalities. |
| Interventions |
Thiazide vs placebo.
Patients were randomly allocated to receive either treatment (chlorothiazide 40 mg/kg/day and spironolactone 4 mg/kg/day divided in 2 doses per day) (N=25) or placebo (N=24). The medications were continued until the infant was weaned off O2. When the infant was stable without supplemental O2 for 1 week, the dose was tapered over a 1‐2 week period and then discontinued. Total duration of randomized therapy was similar in the treatment group (138±58 days) and in the control group (148±49 days). |
| Outcomes |
Main outcome: to determine whether patients benefit from continuing diuretic administration until they no longer require oxygen. Secondary outcome: natural history of BPD, by measuring pulmonary mechanics during the first year of life. |
| Notes |
The authors measured thoracic gas volume and airway resistance by plethysmography and dynamic compliance using an esophageal balloon. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomized trial, parallel design |
| Allocation concealment (selection bias) |
Unclear risk |
Blinding of randomization: unclear: All investigators but one were blinded. The role of this investigator in the study and in patient care is not clearly stated. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Blinding of intervention: unclear
Blinding of outcome: unclear |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Complete follow‐up: no: 43 out of 49 patients completed the study. Six were eliminated, three in each group, including 5 at the request of the parents and 1 because parents moved out of state. |
