Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119002
Status:
COMPLETED
Last Update Posted:
2008-03-14
First Post:
2005-07-01
Brief Title:
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis A Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studyThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None