Community Care for Croup (RCT)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Prednisone Prednisone, 2mg/kg for 3 days |
Drug: Prednisone
2 mgs/kg for 3 days
|
Active Comparator: Dexamethasone Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days |
Drug: Dexamethasone
0.6 mgs for one day, then placebo for 2 days
|
Outcome Measures
Primary Outcome Measures
- Additional Health Care [11 days]
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 [12 days]
- Nights With Disturbed Sleep [12 days]
- Parental Stress [12 days]
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 [12 days]
- Number of Participants With Reported Side Effects [12 days]
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- Washington University Pediatric and Adolescent Ambulatory Research Consortium
Investigators
- Principal Investigator: Jane M Garbutt, MB, ChB, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09-0542
- NIH/NCRR UL1RR024992
Study Results
Participant Flow
Recruitment Details | Children were recruited from 10 primary care pediatric practices over two winters: between October 26, 2009 and April 16, 2010; and between September 6, 2010 and April 29, 2011. |
---|---|
Pre-assignment Detail | 103 children were assessed for eligibility. 16 were excluded prior to randomization. reasons were: did not meet inclusion criteria (10), declined to participte (6). |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Period Title: Overall Study | ||
STARTED | 41 | 46 |
COMPLETED | 40 | 45 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Prednisone | Dexamethasone | Total |
---|---|---|---|
Arm/Group Description | Total of all reporting groups | ||
Overall Participants | 41 | 46 | 87 |
Age (Count of Participants) | |||
<=18 years |
41
100%
|
46
100%
|
87
100%
|
Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
2.67
(1.43)
|
3.11
(1.58)
|
2.9
(1.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
13
31.7%
|
18
39.1%
|
31
35.6%
|
Male |
28
68.3%
|
28
60.9%
|
56
64.4%
|
Region of Enrollment (participants) [Number] | |||
United States |
41
100%
|
46
100%
|
87
100%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Number (95% Confidence Interval) [percentage of participants] |
7
17.1%
|
2
4.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Prednisone, Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.34 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Duration of Croup Symptoms |
---|---|
Description | |
Time Frame | 12 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Mean (Standard Deviation) [days] |
2.2
(1.3)
|
2.8
(2.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Prednisone, Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.63 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Nights With Disturbed Sleep |
---|---|
Description | |
Time Frame | 12 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Mean (Standard Deviation) [nights] |
1.21
(2.69)
|
0.68
(1.55)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Mean (Standard Deviation) [days] |
1.56
(2.69)
|
1.39
(1.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Prednisone, Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.51 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Time Missed From Work |
---|---|
Description | |
Time Frame | 12 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Mean (Standard Deviation) [Hours] |
3.79
(7.40)
|
4.06
(5.54)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Prednisone, Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.24 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Number of Participants With Reported Side Effects |
---|---|
Description | |
Time Frame | 12 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Prednisone | Dexamethasone |
---|---|---|
Arm/Group Description | ||
Measure Participants | 40 | 45 |
Number [percentage of participants] |
26
63.4%
|
24
52.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Prednisone, Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.0 |
Comments | ||
Method | Fisher Exact | |
Comments |
Adverse Events
Time Frame | 28 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Prednisone | Dexamethasone | ||
Arm/Group Description | ||||
All Cause Mortality |
||||
Prednisone | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Prednisone | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/41 (0%) | 0/46 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Prednisone | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/41 (0%) | 0/46 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Jane Garbutt |
---|---|
Organization | Washington University School of Medicine |
Phone | 314-454-8613 |
jgarbutt@dom.wustl.edu |
- 09-0542
- NIH/NCRR UL1RR024992