Corneli 2007.
| Methods | Parallel design, 2‐arm Multi‐centre (20), conducted in the US (centres from the Pediatric Emergency Care Applied Research Network ‐ PECARN) |
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| Participants | Outpatients (emergency department) Inclusion/exclusion criteria Inclusion criteria: age 2 to 12 mo.; 1st episode of bronchiolitis (no wheezing, asthma, no previous use of bronchodilators); within 7 days onset; moderate to severe (RDAI ≥ 6) Exclusion criteria: prior adverse event to dexamethasone; heart or lung disease; premature birth (< 36 weeks); immunosuppression or immunodeficiency; therapy with glucocorticoids in previous 14 d; active or recent exposure to varicella; critically ill; parent inability to speak English/Spanish Participant characteristics All groups Sample size: randomised (N): 600, analysed ‐ review/trial primary outcome (N): 600 (ITT with all data used; also performed per protocol analysis) GROUP 1 Sample size: randomised (N): 305, analysed ‐ review/trial primary outcome (N): 305 Age, mean ± SD: 5.1 ± 2.6 months Males, N (%): 190 (62.5) RSV status: 85/127 positive GROUP 2 Sample size: randomised (N): 295, analysed ‐ review/trial primary outcome (N): 295 Age, mean ± SD: 5.1 ± 2.8 months Males, N (%): 178 (60.5) RSV status: 81/142 positive Atopic status: NR (reported family history of wheezing) |
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| Interventions |
GROUP 1 (with glucocorticoid)
Drug name: dexamethasone
Dose: 1 mL/kg (max 12 mg); oral solution = 1 mg/mL of liquid from generic dexamethasone phosphate injection solution
Mode of administration: oral
Timing/duration: 1 dose GROUP 2 Drug name: placebo (NR) Dose: 1 mL/kg (max 12 mg) Mode of administration: oral Timing/duration: 1 dose Additional co‐interventions for all groups: reported use of albuterol, epinephrine Protocolised use of bronchodilators with glucocorticoids: no |
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| Outcomes |
Primary outcome/outcome used to calculate sample size
Hospital admission (at 4 hours) Secondary outcomes Length of stay for admitted patients; SaO2*; respiratory rate *; heart rate *; temperature*; clinical scale: Respiratory Assessment Change Score, a change score based on RDAI and respiratory rate change from baseline*; hospital re‐admission#; return healthcare visits#; adverse events# *time points: 4 hours #time points: within 7 to 10 days |
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| Funding | Grant from the Maternal and Child Health Research program and co‐operative agreements with the Emergency Medical Services for Children program of the Maternal and Child Health Bureau, Health Resources and Services Administration | |
| Notes | Study reported subgroup analyses of patients with eczema or a family history of asthma (pre‐specified), RSV positive and aged < 6 months; adjusted analysis plan with interaction terms 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 | "computerized randomization"; "random permuted blocks stratified by center" |
| Allocation concealment (selection bias) | Low risk | "randomization by telephone, using the keypad for data entry" |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | Low risk | "emergency department staff, study personnel, and parents and guardians were unaware of the group assignments."; "randomization codes were secured until all data entry was complete."; "research pharmacies prepared oral dexamethasone solutions ... and identical oral placebo solutions. The preparations were packaged in identical clear plastic vials labeled only with the randomization numbers." |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | "emergency department staff, study personnel, and parents and guardians were unaware of the group assignments."; "randomization codes were secured until all data entry was complete."; "research pharmacies prepared oral dexamethasone solutions ... and identical oral placebo solutions. The preparations were packaged in identical clear plastic vials labeled only with the randomization numbers." |
| Blinding (performance bias and detection bias) Other outcomes (adverse events, others) | Low risk | "emergency department staff, study personnel, and parents and guardians were unaware of the group assignments."; "randomization codes were secured until all data entry was complete."; "research pharmacies prepared oral dexamethasone solutions ... and identical oral placebo solutions. The preparations were packaged in identical clear plastic vials labeled only with the randomization numbers." |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Low risk | Primary outcome ITT, all analysed; no missing primary outcome data. For secondary outcomes, less than 10% follow‐up data lost; balanced between groups; motives reported |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | Secondary outcomes were also assessed per protocol; less than 10% follow‐up data lost; balanced between groups; motives reported |
| Incomplete outcome data (attrition bias) Other outcomes (adverse events, others) | Low risk | Secondary outcomes were also assessed per protocol; less than 10% follow‐up data lost; balanced between groups; motives reported |
| Selective reporting (reporting bias) | Low risk | Published report includes all pre‐specified and expected outcomes; study protocol was available |
| Other bias | Low risk | No significant baseline imbalances; no other sources of bias |
| Overall risk of bias | Low risk | All applicable domains low risk of bias |