Sharma 2013.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: inpatient ward of a tertiary care teaching hospital in India Assessed for eligibility: 277 Randomised: 125 hypertonic saline group; 125 normal saline group Completed: 125 hypertonic saline group; 123 normal saline group Gender (male): 76.2% Age (mean ± SD): 8.5 ± 5.0 months Inclusion criteria: infants aged 1 to 24 months, hospitalised with moderate (clinical severity score 3 to 6) acute bronchiolitis, defined by the first episode of wheezing along with prodrome of upper respiratory tract infection Exclusion criteria: children with obtunded consciousness, cardiac disease, chronic respiratory disease, previous wheezing episode, progressive respiratory distress requiring respiratory support other than supplemental oxygen, use of nebulised hypertonic saline within the previous 12 h |
|
Interventions | Intervention group: nebulised 3% hypertonic saline (4 mL) plus salbutamol (2.5 mg) Control group: nebulised 0.9% normal saline (4 mL) plus salbutamol (2.5 mg) The medication was given via a jet nebuliser with tight‐fitting face mask, driven by oxygen flow at 7 L/min, every 4 h until the infant was 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) | Low risk | Study solutions were similar in colour, smell, and other physical properties. The code of the therapeutic package (hypertonic saline versus normal saline solution) was deposited with the statistician. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 (0.8%) withdrawals after randomisation in normal saline group |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
Other bias | Low risk | No other bias found. |