Mahesh Kumar 2013.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: inpatient ward of a teaching hospital in India Assessed for eligibility: 78 Randomised: 20 hypertonic saline group; 20 normal saline group Completed: 20 hypertonic saline group; 20 normal saline group Gender (male): 62.5% Age (mean ± SD): 5.9 ± 3.8 months Inclusion criteria: children aged < 2 years, hospitalised with acute bronchiolitis defined as the first episode of lower respiratory tract infection with wheeze and having a moderate respiratory distress with clinical severity score between 4 and 8 Exclusion criteria: children with pre‐existing cardiac disease, previous wheezing episodes, severe disease (clinical severity score > 8) requiring mechanical ventilation (SaO₂ < 85% on room air, cyanosis, obtunded consciousness, and/or progressive respiratory failure) |
|
Interventions | Intervention group: nebulised 3% hypertonic saline (3 mL) plus salbutamol (0.15 mg/kg) Control group: nebulised 0.9% normal saline (3 mL) plus salbutamol (0.15 mg/kg) The medication was given via a nebuliser driven by oxygen flow at 5 to 6 L/min, every 6 h until ready for discharge. | |
Outcomes |
|
|
Notes | Virological identification not available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | The trial was stated as double‐blind, but no details were provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported. |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
Other bias | Low risk | No other bias found. |