Methods |
Randomized, double‐blind, placebo‐controlled clinical trial |
Participants |
Outpatients less than 15 months old, with first episode of wheezing. Median age 5.5 months, 56% male, no underlying lung/cardiac disease. 48% RSV‐positive
Country: USA |
Interventions |
Group 1: nebulized salbutamol in 3 ml saline, Group 2: nebulized saline placebo in 3 ml saline, Group 3: oral salbutamol, Group 4: oral saline placebo. Dose of salbutamol 0.15 mg/kg/dose. Nebulized group received 2 nebulizations 30 minutes apart and oral groups received 1 dose. Nebulization with compressed air at 6 L/min via Up‐mist nebulizer with pediatric face mask. Infants 7 kg or less received 1 unit dose of 1 mg salbutamol solution for inhalation (5 mg/ml) or 1 oral dose of 2.5 ml |
Outcomes |
Respiratory rate, heart rate, clinical score (4‐point score for each of grunting, nasal flaring, supraclavicular and intercostal retractions, air entry, air hunger, duration of wheeze in respiratory cycle, location of wheeze, general appearance), oxygen saturation, infant's state. Side effects: flushing of face, hyperactivity, increased coughing, tremors |
Notes |
Nebulized treatment group: in order to represent the results from the 2 bronchodilator treatment arms (nebulized and oral), this study is listed twice. Each treatment group had its own placebo group |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
|
Allocation concealment (selection bias) |
Low risk |
|
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
|
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
Selective reporting (reporting bias) |
Low risk |
|