Back to resultsCommunity Care for Croup (RCT)
Primary Purpose
Croup
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Croup focused on measuring Primary Care, Treatment, Croup, Corticosteroids, Prednisone, Dexamethasone, Randomized trial
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prednisone
Dexamethasone
Arm Description
Prednisone, 2mg/kg for 3 days
Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of Croup Symptoms
Nights With Disturbed Sleep
Parental Stress
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.
Time Missed From Work
Number of Participants With Reported Side Effects
Full Information
NCT ID
NCT01042145
First Posted
January 4, 2010
Last Updated
September 11, 2014
Sponsor
Washington University School of Medicine
Collaborators
Washington University Pediatric and Adolescent Ambulatory Research Consortium
1. Study Identification
Unique Protocol Identification Number
NCT01042145
Brief Title
Community Care for Croup (RCT)
Official Title
Community Care for Croup (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Washington University Pediatric and Adolescent Ambulatory Research Consortium
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Croup
Keywords
Primary Care, Treatment, Croup, Corticosteroids, Prednisone, Dexamethasone, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone, 2mg/kg for 3 days
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
2 mgs/kg for 3 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
0.6 mgs for one day, then placebo for 2 days
Primary Outcome Measure Information:
Title
Additional Health Care
Description
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.
Time Frame
11 days
Secondary Outcome Measure Information:
Title
Duration of Croup Symptoms
Time Frame
12 days
Title
Nights With Disturbed Sleep
Time Frame
12 days
Title
Parental Stress
Description
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.
Time Frame
12 days
Title
Time Missed From Work
Time Frame
12 days
Title
Number of Participants With Reported Side Effects
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane M Garbutt, MB, ChB
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24092872
Citation
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.
Results Reference
result
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Community Care for Croup (RCT)
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