Community Care for Croup (RCT)

This study has been completed.
Washington University Pediatric and Adolescent Ambulatory Research Consortium
Information provided by:
Washington University School of Medicine Identifier:
First received: January 4, 2010
Last updated: August 3, 2011
Last verified: August 2011

This randomized clinical trial to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of 200 children with mild or moderate croup will be conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes include additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events.Our hypothesis is 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: 28 days ] [ Designated as safety issue: No ]

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 ]
  • days missed from work [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: June 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 Drug: Prednisone
2 mgs/kg for 3 days
Active Comparator: Dexamethasone 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;
  • prescribed a controller medication or oral steroids for asthma in the past 12 months;
  • a history of TB 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Dr. Jane Garbutt - Principal Investigator, Washington University Identifier: NCT01042145     History of Changes
Other Study ID Numbers: 09-0542, NIH/NCRR UL1RR024992
Study First Received: January 4, 2010
Last Updated: August 3, 2011
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
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on July 26, 2014