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

Florin 2014.

Methods Design: randomised, double‐blind, parallel‐group, controlled trial
Participants Setting: urban paediatric emergency department in USA
 Assessed for eligibility: 2256
 Randomised: 31 hypertonic saline group (3% saline); 31 normal saline group
 Completed: 31 hypertonic saline group; 31 normal saline group
 Gender (male): 45.2%
 Age (mean ± SD): 7.2 ± 5.1 months in hypertonic saline group; 6.1 ± 3.6 months in normal saline group
Inclusion criteria: children aged 2 months up to 24 months presenting to the emergency department with acute bronchiolitis, defined as a first episode of wheezing associated with signs and symptoms of respiratory distress and upper respiratory infection, with RDAI score of 4 to 15 (moderate to severe)
Exclusion criteria: infants with a history of wheezing or asthma, bronchodilator therapy prior to the current illness, chronic lung or heart disease, critical illness, inability to receive nebulised medications, and infants with non–English‐speaking guardians
Interventions Intervention group: nebulised 3% hypertonic saline (4 mL)
Control group: nebulised 0.9% normal saline (4 mL)
Treatment delivered using a jet nebuliser with an oxygen flow rate of 8 L/min. Study medication was given within 90 minutes after albuterol administration.
Outcomes
  • Respiratory assessment change score (RACS)

  • Heart rate

  • Respiratory rate

  • Oxygen saturation

  • Rate of hospitalisation

  • Physician clinical impression (i.e. overall rating of clinical severity, categorised as mild, moderate, or severe)

  • Parental perception of improvement in breathing and feeding (i.e. improved, worse, or unchanged)

  • Adverse events

Notes Virological identification not available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random permuted block randomisation
Allocation concealment (selection bias) Low risk The investigational pharmacy prepared the study medications, which were stored in sequentially numbered envelopes with blinded syringes labelled only with the study number.
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.