Luo 2010.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: inpatient wards of a teaching hospital for children in China
Eligible: not stated
Randomised: 50 hypertonic saline group; 43 normal saline group
Completed: 50 hypertonic saline group; 43 normal saline group
Gender (male): 60.2%
Age (mean ± SD): 6.0 ± 4.3 months in hypertonic saline group; 5.6 ± 4.5 months in normal saline group Inclusion criteria: infants with a diagnosis of mild to moderately severe bronchiolitis Exclusion criteria: age > 24 months, previous episode of wheezing, chronic cardiac and pulmonary disease, immunodeficiency, accompanying respiratory failure, requiring mechanical ventilation, inhaling the nebulised 3% hypertonic saline solution and salbutamol 12 h before treatment, and premature infants born at less than 34 weeks gestation |
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Interventions | Intervention group: nebulised 3% hypertonic saline (4 mL) plus 2.5 mg salbutamol Control group: nebulised 0.9% normal saline (4 mL) plus 2.5 mg salbutamol Infants in each group received 3 treatments every day, delivered at intervals of 8 h until discharge using air‐compressed nebulisers. | |
Outcomes |
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Notes | RSV positive: 70% in hypertonic saline group; 69.7% in normal saline group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details were reported. |
Allocation concealment (selection bias) | Low risk | No detectable difference in colour, smell, or other physical properties between the therapeutic packages containing 0.9% saline solution or 3% saline solution. The codes of the therapeutic packages were not available to the investigators, nurses, or parents. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
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. |