CTRI/2017/02/007919.

Study name	CTRI/2017/02/007919
Methods	Trial registration: CTRI/2017/02/007919 Study design: randomised, parallel‐group, placebo‐controlled trial Setting and centres: single centre, emergency department, Department of Paediatrics, GMSH, Chandigarh, India Dates of study: first enrolment 12 January 2017 Duration of study: intervention duration: 3 hour; outcome assessment duration: until child was discharged Inclusion criteria: children aged 2 to 12 months with diagnosis of acute bronchiolitis, with short history of cough, with or without fever of less than 7 days duration, wheezing on examination, first attack of wheezing. Exclusion criteria: past history of wheezing, family history of bronchial asthma, presence of congenital heart disease or congenital malformation, history of prematurity or mechanical ventilation in newborn period, pneumonia or pleural effusion, SAM, very sick child with shock, seizures, tachycardia (HR > 200/minute), and respiratory failure, foreign body ingestion, history of nebulisation of any drug
Participants	Plan to randomise 104 infants
Interventions	Intervention: magnesium sulphate nebulisation: enrolled cases in the intervention group shall be given 40 mg/kg magnesium sulphate nebulisation, diluted with 2 mL to 3 mL normal saline. 3 doses of medication will be given at 1‐hour intervals, and will not be repeated after 3 doses Comparator: oxygen therapy, IV fluids or oral feeds: this group will be treated with oxygen therapy, IV fluids, or oral feeds, symptomatic treatment for fever, and supportive care Concomitant treatment in both study arms: none written
Outcomes	Primary outcomes: improvement in severity of bronchiolitis, measured with the Respiratory Distress Assessment Instrument (RDAI) score. Timepoint: RDAI score shall be assessed at admission, at 3, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96 hours, and at discharge. Secondary outcomes: Duration of hospital stay; time point: at discharge Improvement in SpO₂; time point: improvement in SpO₂ assessed at admission, at 3, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96 hours, and at discharge
Starting date	12 January 2017
Contact information	Name: Dr Neeraj Dhawan Email: ndhawan_6144@yahoo.com; p.sadbhavna@yahoo.com Address: Department of Paediatrics, Government Multispeciality Hospital, Chandigarh, India
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