Jacobs 2014.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: emergency department of an urban tertiary care centre in the USA
Assessed for eligibility: 128
Randomised: 52 hypertonic saline group; 49 normal saline group
Completed: 52 hypertonic saline group; 49 normal saline group
Gender (male): 63.3%
Age (mean ± SD): 6.0 ± 3.9 months in hypertonic saline group; 5.6 ± 3.3 months in normal saline group Inclusion criteria: infants aged 6 weeks to 18 months presenting to the emergency department with acute bronchiolitis, defined as viral respiratory illness and first episode of wheeze, and a modified Wang clinical severity score of ≥ 4 Exclusion criteria: previous history of wheezing, any use of bronchodilators within 2 hours of presentation, gestational age ≤ 34 weeks, history of congenital heart disease or chronic pulmonary or chronic renal disease, SaO₂ ≤ 85% at the time of recruitment, severe disease requiring ICU admission, or inability to obtain informed consent |
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Interventions | Intervention group: nebulised 7% hypertonic saline (3 mL) plus 2.25% racaemic epinephrine (0.5 mL)
Control group: nebulised 0.9% hypertonic saline (3 mL) plus 2.25% racemic epinephrine (0.5 mL) The medication was given via a nebuliser driven by oxygen flow at 6 L/min after initial screening and assessment. If admitted, the infant continued to receive the same designated medication every 6 h until discharge or 24 h after admission. |
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Outcomes |
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Notes | RSV positive: 68% in hypertonic saline group; 50% in control group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation in blocks of 10, but it is unclear how to choose blocks at random to create the allocation sequence. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, concealed envelopes containing either 7% or 0.9% saline solution |
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. |