The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
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ClinicalTrials.gov Identifier: NCT00119002 |
Recruitment Status :
Completed
First Posted : July 12, 2005
Last Update Posted : March 14, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bronchiolitis, Viral | Drug: dexamethasone Drug: Placebo | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 598 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Dexamethasone
1mg of Dexamethasone/kg
|
Drug: dexamethasone
1mg/kg dexamethasone |
Placebo Comparator: Placebo
1mg/kg placebo
|
Drug: Placebo
1mg/kg placebo |
- Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ]
- 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 ]

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Ages Eligible for Study: | 2 Months to 11 Months (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119002
United States, Utah | |
Primary Children's Medical Center | |
Salt Lake City, Utah, United States, 84158-0249 |
Principal Investigator: | Howard Corneli, MD | University of Utah |
Publications of Results:
Responsible Party: | Howard Corneli, MD Principal Investigator, University of Utah |
ClinicalTrials.gov Identifier: | NCT00119002 |
Other Study ID Numbers: |
R40MC04298-01-00 |
First Posted: | July 12, 2005 Key Record Dates |
Last Update Posted: | March 14, 2008 |
Last Verified: | January 2008 |
randomized clinical trial placebo-controlled double-blind double-masked |
infant dexamethasone wheezing |
Bronchiolitis, Viral Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Virus Diseases Dexamethasone Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |