Methods |
Randomized, double‐blind, placebo‐controlled trial |
Participants |
Setting: inpatients
Infants less than 1 year of age, hospitalized for moderate to severe bronchiolitis, first episode of wheezing. Chest X‐ray compatible with bronchiolitis. Mean age 5.1 ± 2.7 months. No prematurity; chronic neurological or cardiopulmonary disease, including asthma; proven or suspected acute bacterial infection; previous treatment with bronchodilators or corticosteroids; infants younger than 4 weeks old and who needed ventilation at neonatal period; symptoms present for more than 7 days; fever higher than 38.5 °C; or infants with mild bronchiolitis.
Country: Turkey |
Interventions |
Group 1: nebulized salbutamol solution (Ventolin, Glaxo) plus saline solution (0.9%) 2.5 ml every 6 hours. Group 2: ipratropium bromide (Atrovent, Boehringer Ingelheim) 250 µg/2 ml plus 3 ml saline solution every 6 hours
Group 3: normal saline received 5 ml every 6 hours |
Outcomes |
Changes in the oxygen saturation rates, clinical scores and duration of hospital stay. Adverse effects were recorded, i.e. tachycardia and tremor after nebulization of each medication
The clinical score system was based on respiratory rate, degree of wheezing, degree of accessory muscle use and general condition, described by Wang 1992. Improvement was defined as a decrease by 2 points in the total clinical score |
Notes |
Ipratropium (IPR) treatment group: in order to represent the results from the 2 bronchodilator treatment arms (ipratropium and salbutamol), this study is listed twice. The placebo group was divided between comparisons to avoid double‐counting of placebo participants |
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) |
High risk |
Data on heart rate mentioned but not presented in results |