Wu 2014.
| Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
| Participants | Setting: emergency departments of 2 urban freestanding tertiary children’s hospitals in USA Assessed for eligibility: 1254 Randomised: 211 hypertonic saline group; 197 normal saline group Completed: 211 hypertonic saline group; 197 normal saline group Gender (male): 56.8% Age (mean ± SD): 6.5 ± 5.1 months in hypertonic saline group; 6.4 ± 5.3 months in normal saline group Inclusion criteria: children younger than 24 months with a primary diagnosis of viral bronchiolitis during bronchiolitis season Exclusion criteria: children with a prior illness with wheezing or bronchodilator use, premature (gestational age < 34 weeks), cyanotic congenital heart disease, chronic lung disease, or tracheostomy |
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| Interventions | Intervention group: nebulised 3% hypertonic saline (4 mL) Control group: nebulised 0.9% normal saline (4 mL) The solutions were given via a small‐volume wall nebuliser at study entry. Emergency department physicians could order 2 additional treatments every 20 minutes to a maximum of 3 inhaled doses. Admitted infants continued receiving study medication, every 8 h until discharge. |
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| Outcomes |
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| Notes | RSV positive: 65.6% hypertonic saline group; 59.2% normal saline group | |
| 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 | Saline solutions were prepared by the investigational pharmacy and stored in sequentially numbered identical vials. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported at emergency department setting. |
| Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
| Other bias | Low risk | No other bias found. |
ICU: intensive care unit RDAI: Respiratory Distress Assessment Instrument RSV: respiratory syncytial virus SaO₂: oxygen saturation SD: standard deviation