Community Care for Croup (RCT)

NCT01042145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2014-09-15

Study results available
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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.

Conditions

  • Croup

Interventions

DRUG

Prednisone

2 mgs/kg for 3 days

DRUG

Dexamethasone

0.6 mgs for one day, then placebo for 2 days

Sponsors & Collaborators

  • Washington University Pediatric and Adolescent Ambulatory Research Consortium

    collaborator NETWORK
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jane M Garbutt, MB, ChB · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042145 on ClinicalTrials.gov