NCT02233985.

Methods	Randomised, double‐blind, parallel‐group, controlled trial
Participants	Children aged 2 to 24 months attending the paediatric emergency service with moderate to severe bronchiolitis, defined as first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection
Interventions	Nebulised 3% hypertonic saline (4 mL) plus salbutamol (100 mcg/kg) versus nebulised 0.9% normal saline (4 mL) plus salbutamol (100 mcg/kg) 3 doses of study solutions were initially given at an interval of 20 minutes, then every 4 hours during the entire hospital stay.
Outcomes	Primary outcomes: Respiratory distress score (at baseline, 30 minutes after the end of the first 3 continuous nebulisation sessions, at 4 hours, 8 hours, and every 24 hours during the entire hospital stay) Length of hospital stay (hours) Secondary outcomes: Hospital re‐admission within 30 days after discharge Frequency of complications within 30 days after discharge
Notes	Starting date: August 2013 Completion of data collection: April 2015 Last updated: 25 January 2017 Contact information: Gloria P Sosa‐Bustamante, MD, Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco ‐ Pediatria, Instituto Mexicano del Seguro Social, Mexico