Clinical Trial: The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial

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 Summary:

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.


Sponsor: University of Utah

Current Primary Outcome: Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ]

Original Primary Outcome: Hospital admission after 4 hours of ED observation

Current Secondary Outcome:

  • Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry. [ Time Frame: 4 hours ]
  • Duration of hospitalization (if admitted) measured at 7-to-10 day followup. [ Time Frame: 7-10 days ]
  • Safety, toleration, and parental satisfaction measured at 7-to-10 day followup. [ Time Frame: 7-10 days ]


Original Secondary Outcome:

  • Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.
  • Duration of hospitalization (if admitted) measured at 7-to-10 day followup.
  • Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.


Information By: University of Utah

Dates:
Date Received: July 1, 2005
Date Started: January 2004
Date Completion:
Last Updated: March 13, 2008
Last Verified: January 2008