Ojha 2014.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: inpatient ward of a teaching hospital in Nepal Assessed for eligibility: 104 Randomised: 36 hypertonic saline group; 36 normal saline group Completed: 28 hypertonic saline group; 31 normal saline group Gender (male): 74% Age (mean ± SD): 8.5 ± 5.0 months Inclusion criteria: children aged over 6 weeks up to 24 months, hospitalised with acute bronchiolitis, defined as the first episode of wheezing associated with tachypnoea, increased respiratory effort, and an upper respiratory tract infection Exclusion criteria: 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, premature infants born at less than 34 weeks gestation, SaO₂ < 85% on room air |
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Interventions | Intervention group: nebulised 3% hypertonic saline (4 mL) Control group: nebulised 0.9% normal saline (4 mL) The treatment was given every 8 h until discharge. |
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Outcomes |
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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 | The random numbers were kept in a sealed envelope. The solutions looked similar in appearance and smell and were kept in 2 identical containers, labelled only by a code number. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 13 (18%) withdrawals after randomisation (8 hypertonic saline group; 5 normal saline group); baseline characteristics between treatment groups were balanced. |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
Other bias | Low risk | No other bias found. |