Community Care for Croup (RCT)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Additional Health Care
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Year to 8 Years (Child)
- Sex
- All
- 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.
Arms & Interventions
Prednisone
Prednisone, 2mg/kg for 3 days
Intervention: Prednisone (Drug)
Dexamethasone
Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Duration of Croup Symptoms(12 days)
- Nights With Disturbed Sleep(12 days)
- Parental Stress(12 days)
- Time Missed From Work(12 days)
- Number of Participants With Reported Side Effects(12 days)
Investigators
Jane Garbutt, MD
Associate Professor
Washington University School of Medicine