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. 2013 Jun 4;2013(6):CD004878. doi: 10.1002/14651858.CD004878.pub4

Mesquita 2009.

Methods Parallel design, 2 arms
Single‐centre, conducted in Paraguay (Hospital General Pediátrico “Niños de Acosta Ñu”, Asunción)
Participants Outpatients (paediatric emergency department)
Inclusion/exclusion criteria 
 Inclusion criteria: age 2 to 24 mo.; 1st episode of bronchiolitis defined as respiratory distress, respiratory rate 40 to 80 bpm, wheezing; < 7 d after onset of cold
 Exclusion criteria: clinical or radiological pneumonia; cardiopulmonary congenital malformations; bronchopulmonary dysplasia; cystic fibrosis; foreign body aspirations;
 neurological alteration; previous wheezing or asthma episode; inhaled or systemic glucocorticoid < 15 d; β2‐agonists < 4 hours; history of atopy in the child (dermatitis or allergic rhinitis) or parental asthma; severe wheezing attack (respiratory rate ≥ 100/minute and/or heart rate ≥ 200/minute and/or shock or lethargy)
Participant characteristicsAll groups 
 Sample size: randomised (N): 80, analysed ‐ trial/review primary outcomes (N): 65 (per protocol analysis was used)
GROUP 1 
 Sample size: randomised (N): NR, analysed ‐ trial/review primary outcomes (N): 33
Age, mean ± SD: 7.3 ± 4 months
 Males, N (%): 19 (58)
 RSV status: 17/29 positive
GROUP 2 
 Sample size: randomised (N): NR, analysed ‐ trial/review primary trial outcome (N): 32 (available case analysis was used)
Age, mean ± SD: 5.9 ± 3 months
 Males, N (%): 15 (47)
 RSV status: 19/23 positive
Atopic status: NR
Interventions GROUP 1 (with glucocorticoid) 
 Drug name: dexamethasone
 Dose: 0.5 mg/kg (1 mL/kg)
 Mode of administration: oral
 Timing/duration: 1 dose
 
 GROUP 2 
 Drug name: placebo (NR)
 Dose: 1 mL/kg
 Mode of administration: oral
 Timing/duration: 1 dose
 Co‐interventions:
Additional co‐interventions for all groups: all patients received 4 mL physiological solution during a 6‐minute nebulisation with 02 flow of 6 L/minute; after 30 minutes, a dose of 1 mL L‐adrenaline solution (1:1000, 1 mL = 1 mg) was received by nebulisation
 Protocolised use of bronchodilators with glucocorticoids: yes (epinephrine)
Outcomes Primary outcome/outcome used to calculate sample size 
 Clinical scale*: RDAI, 17‐point score based on wheezing and retractions (at 4 h; other time points*)
Secondary outcomes 
 Hospital admission (at 4 hours); SaO2*; respiratory rate*; heart rate*
 *time points: 60 minutes, 4 hours
Funding NR (Lab. Formula Magistral, Asunción, Paraguay provided drugs)
Notes Study did not report any study‐level subgroup analyses
This study contributed to the following comparisons in this review: steroid versus placebo
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "patients were randomised to a double‐blind, placebo‐control study using a table of random numbers"
Allocation concealment (selection bias) Low risk "The research pharmacy prepared the active drug ... and the placebo ...; their bottles were labelled only with the randomised numbers."
Blinding (performance bias and detection bias) 
 Health care use ((re)admissions, LOS, return visits) Low risk Double‐blind; "The research pharmacy prepared the active drug (dexamethasone, Lab. Formula Magistral, Paraguay) and the placebo in identical sweet syrups and their bottles were labelled only with the randomised numbers."; in the whole period of the trial, the investigators were blinded of the treatment administered."
Blinding (performance bias and detection bias) 
 Clinical parameters (severity scales, SpO2, respiratory and heart rate) Low risk Double‐blind; "The research pharmacy prepared the active drug (dexamethasone, Lab. Formula Magistral, Paraguay) and the placebo in identical sweet syrups and their bottles were labelled only with the randomised numbers."; in the whole period of the trial, the investigators were blinded of the treatment administered."
Incomplete outcome data (attrition bias) 
 Health care use ((re)admissions, LOS, return visits) Low risk 15 children excluded post‐enrollment, motives reported (2 children quit the protocol before the first hour, 3 post‐treatment)
Incomplete outcome data (attrition bias) 
 Clinical parameters (severity scales, SpO2, respiratory and heart rate) Low risk 15 children excluded post‐enrollment, motives reported (2 children quit the protocol before the first hour, 3 post‐treatment)
Selective reporting (reporting bias) Unclear risk Subgroups not defined in methods; published report includes all pre‐specified and expected outcomes; study protocol was not available
Other bias Low risk No significant baseline imbalances; no other sources of bias
Overall risk of bias Unclear risk Unclear