Bronchiolitis, Viral
Conditions
Keywords
randomized clinical trial, placebo-controlled, double-blind, double-masked, infant, dexamethasone, wheezing
Brief summary
This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study.The primary hypothesis is that dexamethasone will be more effective than placebo in preventing hospital admission. The secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone will be as safe and as well tolerated as placebo.
Detailed description
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the most hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence both for and against the effectiveness of corticosteroids such as dexamethasone has been published. Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and Quality recommend a study such as this one. Patients will be drawn from the emergency departments at participating medical centers in the Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services for Children program and the Maternal and Child Health Bureau of the Health Resources and Services Administration to study health problems of high acuity and high incidence in children. Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and secondary outcomes will be compared between treatment and placebo groups.
Interventions
DRUGdexamethasone
1mg/kg dexamethasone
DRUGPlacebo
1mg/kg placebo
Sponsors
Children's Hospital of Philadelphia
Children's Hospital of Michigan
Children's Hospital Medical Center, Cincinnati
Washington University School of Medicine
Columbia University
Children's National Research Institute
Helen DeVos Children's Hospital
Women & Children's Hospital of Buffalo
University of Rochester
NYU Langone Health
Hurley Medical Center
Boston Children's Hospital
University of Maryland
Johns Hopkins University
Howard County General Hospital
University of California, Davis
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 11 Months
Healthy volunteers
No
Inclusion criteria
* First attack of wheezing within 7 days of onset * Age 2 months through 11 months (less than 12 months) * Disease of at least moderate severity (RDAI score greater than or equal to 6)
Exclusion criteria
* Prior adverse reaction to dexamethasone * Known heart or lung disease * Premature birth prior to 36 weeks' gestation * History of prior asthma or bronchodilator use * Immune suppression or deficiency * Trisomy 21 * Critical or life-threatening complications of bronchiolitis * Treatment with corticosteroids within 14 days * Known active chickenpox * Exposure to chickenpox within 21 days * Child sent to ED for automatic admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital admission after 4 hours of ED observation | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry. | 4 hours |
| Duration of hospitalization (if admitted) measured at 7-to-10 day followup. | 7-10 days |
| Safety, toleration, and parental satisfaction measured at 7-to-10 day followup. | 7-10 days |
Countries
United States
Outcome results
None listed