Clinical Trial: Community Care for Croup (RCT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Community Care for Croup (RCT)

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.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome: 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.


Original Primary Outcome: Additional Health Care [ Time Frame: 28 days ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Duration of Croup Symptoms [ Time Frame: 12 days ]
  • Nights With Disturbed Sleep [ Time Frame: 12 days ]
  • Parental Stress [ Time Frame: 12 days ]
  • days missed from work [ Time Frame: 12 days ]
  • side effects [ Time Frame: 12 days ]


Information By: Washington University School of Medicine

Dates:
Date Received: January 4, 2010
Date Started: October 2009
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014