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. 2017 Dec 21;2017(12):CD006458. doi: 10.1002/14651858.CD006458.pub4

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
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.
Outcomes
  • Modified Wang clinical severity score

  • Rate of hospitalisation

  • Discharge rate at 23 h (observation status)

  • Length of hospital stay

  • Adverse events

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.