Mesquita 2009.
Methods | Parallel design, 2 arms Single‐centre, conducted in Paraguay (Hospital General Pediátrico “Niños de Acosta Ñu”, Asunción) |
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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 characteristics All 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 |
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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) |
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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 |
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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 |
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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 |