NCT00119002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 14, 2008

Status Verified

January 1, 2008

Enrollment Period

2.2 years

First QC Date

July 1, 2005

Last Update Submit

March 13, 2008

Conditions

Bronchiolitis, Viral

Keywords

randomized clinical trialplacebo-controlleddouble-blinddouble-maskedinfantdexamethasonewheezing

Outcome Measures

Primary Outcomes (1)

  • Hospital admission after 4 hours of ED observation

    4 hours

Secondary Outcomes (3)

  • 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

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

1mg of Dexamethasone/kg

Drug: dexamethasone

Placebo

PLACEBO COMPARATOR

1mg/kg placebo

Drug: Placebo

Interventions

dexamethasoneDRUG

1mg/kg dexamethasone

Dexamethasone
PlaceboDRUG

1mg/kg placebo

Placebo

Eligibility Criteria

Age2 Months - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Children's Medical Center

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

Location

Related Publications (1)

  • Corneli HM, Zorc JJ, Mahajan P, Shaw KN, Holubkov R, Reeves SD, Ruddy RM, Malik B, Nelson KA, Bregstein JS, Brown KM, Denenberg MN, Lillis KA, Cimpello LB, Tsung JW, Borgialli DA, Baskin MN, Teshome G, Goldstein MA, Monroe D, Dean JM, Kuppermann N; Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. N Engl J Med. 2007 Jul 26;357(4):331-9. doi: 10.1056/NEJMoa071255.

    PMID: 17652648RESULT

Related Links

MeSH Terms

Conditions

Bronchiolitis, ViralRespiratory Sounds

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Howard Corneli, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

January 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 14, 2008

Record last verified: 2008-01

Locations

US(1)