| Methods |
Blinding of randomization: can't tell. The method of randomization is not provided.
Blinding of intervention: no
Complete follow‐up: yes
Blinding of outcome: inadequate. Investigators performing pulmonary function measurements were not blinded, while those performing final calculations and data analysis were blinded.
Randomized controlled trial, parallel design.
No washout period documented |
| Participants |
Patients entered into the study: n=21
No mechanical ventilation.
Entry criteria included: history of respiratory failure at birth, requiring mechanical ventilation and O2, postnatal age >28 days, O2 needed to maintain oxygen saturation >90%, radiographic evidence of chronic lung disease, no evidence of cor pulmonale or pulmonary infection, no tracheal intubation or mechanical ventilation at the time of the study, full enteral feedings. |
| Interventions |
Thiazide versus no medication.
Patients were randomly allocated to receive either treatment (hydrochlorothiazide 3 mg/kg/day and spironolactone 3 mg/kg/day administered q 12 hours) (N=12) or no medication (control group) for 1 week (N=9). |
| Outcomes |
Main outcome: lung mechanics (dynamic lung compliance and resistance) and oxygenation; secondary outcome: urine output. |
| Notes |
Pulmonary mechanics and oxygenation were measured on the first day and after 1 week of treatment. Dynamic pulmonary mechanics were measured using an esophageal balloon. For patients randomized to thiazide, measurements were started 6 hours after the last diuretic dose. Urine output was obtained at baseline and after 1,2,3,and 4 days of treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The method of randomization is not provided |
| Allocation concealment (selection bias) |
Unclear risk |
Blinding of randomization: can't tell |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding of intervention: no
Blinding of outcome: inadequate. Investigators performing pulmonary function measurements were not blinded, while those performing final calculations and data analysis were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes |
