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 |
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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. |
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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 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. |