Community Care for Croup (RCT)
2 other identifiers
interventional
87
1 country
1
Brief Summary
This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
1 active site
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 4, 2010
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedSeptember 15, 2014
September 1, 2014
1.7 years
January 4, 2010
December 24, 2012
September 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Additional Health Care
The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.
11 days
Secondary Outcomes (5)
Duration of Croup Symptoms
12 days
Nights With Disturbed Sleep
12 days
Parental Stress
12 days
Time Missed From Work
12 days
Number of Participants With Reported Side Effects
12 days
Study Arms (2)
Prednisone
ACTIVE COMPARATORPrednisone, 2mg/kg for 3 days
Dexamethasone
ACTIVE COMPARATORDexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Interventions
Eligibility Criteria
You may qualify if:
- children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup.
You may not qualify if:
- Severe croup or impending respiratory failure;
- another reason to indicate the need for hospitalization;
- symptoms or signs to suggest another cause of stridor;
- active varicella infection;
- diabetes;
- known immunodeficiency disease;
- chronic respiratory disease such as CF (Cystic Fibrosis);
- prescribed a controller medication or oral steroids for asthma in the past 12 months;
- a history of TB(tuberculosis) in a household member;
- treatment for seizures;
- treatment with epinephrine or oral corticosteroids for this croup episode before enrollment;
- not accompanied by their legal guardian;
- the accompanying adult will not be in the same household as the child for the next four days;
- parent/legal guardian is unavailable for telephone follow-up or does not speak English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Garbutt JM, Conlon B, Sterkel R, Baty J, Schechtman KB, Mandrell K, Leege E, Gentry S, Stunk RC. The comparative effectiveness of prednisolone and dexamethasone for children with croup: a community-based randomized trial. Clin Pediatr (Phila). 2013 Nov;52(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3.
PMID: 24092872RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Our failure to demonstrate any difference bewteen the two study groups may be due to the small sample size. We were unable to recruit the targeted sample size of 200.
Results Point of Contact
- Title
- Dr. Jane Garbutt
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jane M Garbutt, MB, ChB
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 4, 2010
First Posted
January 5, 2010
Study Start
October 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 15, 2014
Results First Posted
September 15, 2014
Record last verified: 2014-09