Community Care for Croup (RCT)

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01042145
Collaborator
Washington University Pediatric and Adolescent Ambulatory Research Consortium (Other)
87
1
2
20
4.4

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

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Community Care for Croup (RCT)
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

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

  1. 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

  1. Duration of Croup Symptoms [12 days]

  2. Nights With Disturbed Sleep [12 days]

  3. 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.

  4. Time Missed From Work [12 days]

  5. Number of Participants With Reported Side Effects [12 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Jane Garbutt, MD, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01042145
Other Study ID Numbers:
  • 09-0542
  • NIH/NCRR UL1RR024992
First Posted:
Jan 5, 2010
Last Update Posted:
Sep 15, 2014
Last Verified:
Sep 1, 2014
Keywords provided by Jane Garbutt, MD, Associate Professor, Washington University School of Medicine
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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
3. Secondary Outcome
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)
4. Secondary Outcome
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
5. Secondary Outcome
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
6. Secondary Outcome
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

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.

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
Email jgarbutt@dom.wustl.edu
Responsible Party:
Jane Garbutt, MD, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01042145
Other Study ID Numbers:
  • 09-0542
  • NIH/NCRR UL1RR024992
First Posted:
Jan 5, 2010
Last Update Posted:
Sep 15, 2014
Last Verified:
Sep 1, 2014