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Completed

NCT Number: NCT00119002

The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

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.

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Key information

Age range

2 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Primary Children's Medical Center

Salt Lake City, Utah, 84158-0249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

1mg/kg dexamethasone

Placebo

Drug

1mg/kg placebo

Primary outcomes

  1. Hospital admission after 4 hours of ED observation

    Time frame: 4 hours

Secondary outcomes

  1. Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.

    Time frame: 4 hours

  2. Duration of hospitalization (if admitted) measured at 7-to-10 day followup.

    Time frame: 7-10 days

  3. Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.

    Time frame: 7-10 days

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Boston Children's Hospital
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Michigan
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Columbia University
  • Helen DeVos Children's Hospital
  • Howard County General Hospital
  • Hurley Medical Center
  • Johns Hopkins University
  • NYU Langone Health
  • University of California, Davis
  • University of Maryland
  • University of Rochester
  • Washington University School of Medicine
  • Women & Children's Hospital of Buffalo

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 12, 2005
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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