Flores 2016.

Methods	Design: randomised, double‐blind, parallel‐group, controlled trial
Participants	Setting: paediatric ward of a general urban hospital in Portugal Assessed for eligibility: not stated Randomised: 38 hypertonic saline group (3% saline); 40 normal saline group Completed: 33 hypertonic saline group; 35 normal saline group Gender (male): 52.9% Age (mean ± SD): 3.3 ± 2.4 months hypertonic saline group; 3.8 ± 2.5 months normal saline group Inclusion criteria: infants aged < 12 months with acute bronchiolitis, defined as an apparent viral respiratory tract infection manifest by nasal discharge and wheezy cough, with presence of fine inspiratory crackles and/or high‐pitched expiratory wheeze, even apnoea Exclusion criteria: previous episodes of wheezing, personal history of prematurity (gestational age < 34 weeks), physician diagnosis of eczema, food allergy, or chronic (cardiac, respiratory, immunological, neurological, or metabolic) disease and high severity criteria (coma, respiratory rate > 80 breaths/minute, SaO₂ < 88% on room air or need for assisted ventilation)
Interventions	Intervention group: nebulised 3% hypertonic saline (3 mL) plus 0.25 mL (1.25 mg) salbutamol Control group: nebulised 0.9% normal saline (3 mL) plus 0.25 mL (1.25 mg) salbutamol Treatment was given every 6 h until discharge. All inhaled therapies were delivered through a tight‐fitting face mask from an oxygen‐driven nebuliser (Cirrus 2 Nebuliser, Wokingham, Berkshire, UK), connected to a source of pressurised oxygen from the wall, set to a flow rate of 6 L/min.
Outcomes	Length of hospital stay (fit to discharge and actual discharge) Wang severity score Need for supplemental oxygen and tube feeding and their duration Need for other treatments (further doses of salbutamol, nebulised epinephrine, systemic corticosteroids, antibiotics, or diuretics) Adverse events
Notes	RSV positive: 87.9% in hypertonic saline group; 82.9% in normal saline group
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	Both solutions were similar in appearance and smell, were stored in identical syringes, and were labelled only by a code number. Randomisation list was concealed by the pharmacy.
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	10 (12.8%) withdrawals after randomisation (5 hypertonic saline group, 5 control 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.