Community Care for Croup (RCT)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Washington University Pediatric and Adolescent Ambulatory Research Consortium
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Prednisone

Criteria

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.