Phase 4 N=87 Randomized Triple-blind Treatment

Community Care for Croup (RCT)

Croup

Bottom Line

View on ClinicalTrials.gov: NCT01042145 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Additional Health Care — 7; 2 percentage of participants — p=0.34

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Prednisone (Drug); Dexamethasone (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Additional Health Care	7; 2	0.34
SECONDARY Duration of Croup Symptoms	2.2; 2.8	0.63
SECONDARY Nights With Disturbed Sleep	1.21; 0.68	—
SECONDARY Parental Stress	1.56; 1.39	0.51
SECONDARY Time Missed From Work	3.79; 4.06	0.24
SECONDARY Number of Participants With Reported Side Effects	26; 24	1.0

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01042145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.