Community Care for Croup (RCT)

Croup Clinical Trial

Official title:

Community Care for Croup (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042145
• Other study ID #: 09-0542
• Secondary ID: NIH/NCRR UL1RR02
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2010
• Last updated: September 11, 2014
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Croup

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Washington University Pediatric and Adolescent Ambulatory Research Consortium

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Additional Health Care	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.	11 days	No
Secondary	Duration of Croup Symptoms		12 days	No
Secondary	Nights With Disturbed Sleep		12 days	No
Secondary	Parental Stress	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.	12 days	No
Secondary	Time Missed From Work		12 days	No
Secondary	Number of Participants With Reported Side Effects		12 days	Yes