Teeratakulpisarn 2007.
| Methods | Parallel design, 2 arms Multi‐centre (2), conducted in Thailand (2 tertiary hospitals in the northeast) |
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| Participants | Inpatients Inclusion/exclusion criteria Inclusion criteria: age 4 week to 24 months; 1st episode wheezing with tachypnoea; increased respiratory effort; URTI; criteria for hospitalisation: < 3 months, respiratory rate > 60 bpm (< 12 months) or > 50 bpm (≥ 12 months), SaO2 < 95%, apathy/refusal to eat Exclusion criteria: symptoms > 7 d; admission to ICU with intubation; history of: intubation, asthma, atopy with good response to 1st dose β2‐agonist; therapy with glucocorticoid < 2 weeks; contraindication to glucocorticoid therapy; premature birth Participant characteristics All groups Sample size: randomised (N): 179, analysed ‐ trial/review primary outcomes (N): 174 (per protocol analysis was performed) GROUP 1 Sample size: randomised (N): 90, analysed ‐ trial/review primary outcomes (N): 89 Age, mean ± SD: 10.2 ± 5.5 months Males, N (%): 55 (62) Atopic status: 26 (29) present (family) GROUP 2 Sample size: randomised (N): 89, analysed ‐ trial/review primary outcomes (N): 85 Age, mean ± SD: 11.2 ± 5.9 months Males, N (%): 55 (65) Atopic status: 24 (28) present (family) RSV status: NR |
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| Interventions |
GROUP 1 (with glucocorticoid)
Drug name: dexamethasone
Dose: 0.6 mg/kg
Mode of administration: intramuscular injection
Timing/duration: 1 dose GROUP 2 Drug name: placebo Dose: equivalent volume of saline Mode of administration: intramuscular injection Timing/duration: 1 dose Additional co‐interventions for all groups: use of epinephrine, β2‐agonist nebulisation, O2 permitted and reported (both study groups were similarly treated following the National Treatment Guidelines for Acute Respiratory Infection in Children, Thailand); also reported use of antibiotics. The investigators monitored the treatment regimens in order to avoid any additional form of glucocorticoid being added to either group until the study endpoint was reached Protocolised use of bronchodilators with glucocorticoids: no |
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| Outcomes |
Primary outcome/outcome used to calculate sample size
Time from the study entry to resolution of respiratory distress, recognised by a total clinical score of 3 and an oxygen saturation 95% at room air together with a respiratory rate score of 0 or 1, a wheezing score of 0 or 1, and a retraction muscle score of 0 or 1. Clinical scale developed for this trial, modified from De Boeck et al. and Tal et al ‐ 12‐point score based on respiratory rate, wheezing, accessory respiratory muscle retraction and oxygen saturation* Secondary outcomes Duration of O2 therapy; LOS; hospital re‐admission#, return healthcare visits#; duration of symptoms#; adverse events; additional medications *time points: every 6 hours until the study endpoint was reached #time points: 2‐week intervals, until 1 month |
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| Funding | Grant sponsor: The National Research Council of Thailand | |
| Notes | Study reported subgroup analysis in children under 12 months; no specific interaction term 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 | "Mixed, permuted, block randomization, using a computer‐generated number, was performed for each site and prepared by an off‐site investigator." |
| Allocation concealment (selection bias) | Low risk | "...randomization ... prepared by an off‐site investigator. The study vials were prepared, numbered, and sealed by a pharmacist according to the randomization numbers. The treatment allocation was concealed from the investigators, the attending pediatricians and all of the health personnel involved in patient care." |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | Low risk | Double‐blind; "container of identical appearance" |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | Double‐blind; "container of identical appearance" |
| Blinding (performance bias and detection bias) Patient/parent‐reported outcomes (symptoms, QoL) | Low risk | Double‐blind; "container of identical appearance" |
| Blinding (performance bias and detection bias) Other outcomes (adverse events, others) | Low risk | Double‐blind; "container of identical appearance" |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Low risk | Five participants with missing outcome data; some motives reported |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | Five participants with missing outcome data; some motives reported |
| Incomplete outcome data (attrition bias) Patient/parent‐reported outcomes (symptoms, QoL) | Low risk | Five participants with missing outcome data; some motives reported |
| Incomplete outcome data (attrition bias) Other outcomes (adverse events, others) | Low risk | Five participants with missing outcome data; some motives reported |
| Selective reporting (reporting bias) | Unclear risk | All outcomes specified in methods and results, subgroups not mentioned in methods |
| Other bias | Low risk | No significant baseline imbalances; no other sources of bias |
| Overall risk of bias | Unclear risk | > 1 domain as unclear risk of bias |