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Community Care for Croup (RCT)

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ClinicalTrials.gov Identifier: NCT01042145
Recruitment Status : Completed
First Posted : January 5, 2010
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Washington University Pediatric and Adolescent Ambulatory Research Consortium
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine

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
Croup Drug: Prednisone Drug: Dexamethasone Phase 4

Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Croup Steroids
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Additional Health Care [ Time Frame: 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 [ Time Frame: 12 days ]
  2. Nights With Disturbed Sleep [ Time Frame: 12 days ]
  3. Parental Stress [ Time Frame: 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 [ Time Frame: 12 days ]
  5. Number of Participants With Reported Side Effects [ Time Frame: 12 days ]


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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042145


Locations
United States, Missouri
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

Publications of Results:
Responsible Party: Jane Garbutt, MD, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01042145     History of Changes
Other Study ID Numbers: 09-0542
NIH/NCRR UL1RR024992
First Posted: January 5, 2010    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Jane Garbutt, MD, Washington University School of Medicine:
Primary Care
Treatment
Croup
Corticosteroids
Prednisone
Dexamethasone
Randomized trial

Additional relevant MeSH terms:
Croup
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action