Community Care for Croup (RCT)

This study has been completed.
Washington University Pediatric and Adolescent Ambulatory Research Consortium
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine Identifier:
First received: January 4, 2010
Last updated: September 11, 2014
Last verified: September 2014
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 Intervention Phase
Drug: Prednisone
Drug: Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Community Care for Croup (RCT)

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Additional Health Care [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Nights With Disturbed Sleep [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Parental Stress [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Number of Participants With Reported Side Effects [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT01042145

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
Principal Investigator: Jane M Garbutt, MB, ChB Washington University School of Medicine
  More Information

Responsible Party: Jane Garbutt, MD, Associate Professor, Washington University School of Medicine Identifier: NCT01042145     History of Changes
Other Study ID Numbers: 09-0542  NIH/NCRR UL1RR024992 
Study First Received: January 4, 2010
Results First Received: December 24, 2012
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Primary Care
Randomized trial

Additional relevant MeSH terms:
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses processed this record on February 04, 2016