Community Care for Croup (RCT)

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: Prednisone
    • 2 mgs/kg for 3 days
  • Drug: Dexamethasone
    • 0.6 mgs for one day, then placebo for 2 days

Arms, Groups and Cohorts

  • Active Comparator: Prednisone
    • Prednisone, 2mg/kg for 3 days
  • Active Comparator: Dexamethasone
    • Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Duration of Croup Symptoms
    • Time Frame: 12 days
  • Nights With Disturbed Sleep
    • Time Frame: 12 days
  • 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.
  • Time Missed From Work
    • Time Frame: 12 days
  • Number of Participants With Reported Side Effects
    • Time Frame: 12 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Washington University Pediatric and Adolescent Ambulatory Research Consortium
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jane Garbutt, MD, Associate Professor – Washington University School of Medicine
  • Overall Official(s)
    • Jane M Garbutt, MB, ChB, Principal Investigator, Washington University School of Medicine

Citations Reporting on Results

Garbutt JM, Conlon B, Sterkel R, Baty J, Schechtman KB, Mandrell K, Leege E, Gentry S, Stunk RC. The comparative effectiveness of prednisolone and dexamethasone for children with croup: a community-based randomized trial. Clin Pediatr (Phila). 2013 Nov;52(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3.

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