Community Care for Croup (RCT)

September 11, 2014 updated by: Jane Garbutt, MD, Washington University School of Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prednisone
Prednisone, 2mg/kg for 3 days
Drug: Prednisone
2 mgs/kg for 3 days
Active Comparator: Dexamethasone
Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Drug: Dexamethasone
0.6 mgs for one day, then placebo for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Croup Symptoms
Time Frame: 12 days
12 days
Nights With Disturbed Sleep
Time Frame: 12 days
12 days
Parental Stress
Time Frame: 12 days
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
Time Missed From Work
Time Frame: 12 days
12 days
Number of Participants With Reported Side Effects
Time Frame: 12 days
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Washington University Pediatric and Adolescent Ambulatory Research Consortium

Investigators

  • Principal Investigator: Jane M Garbutt, MB, ChB, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0542
  • NIH/NCRR UL1RR024992

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Croup

Clinical Trials on Prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe