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Completed

NCT Number: NCT01042145

Community Care for Croup (RCT)

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.

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Key information

Conditions

Croup Laryngeal Diseases Laryngitis Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

2 mgs/kg for 3 days

Dexamethasone

Drug

0.6 mgs for one day, then placebo for 2 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of Croup Symptoms

    Time frame: 12 days

  2. Nights With Disturbed Sleep

    Time frame: 12 days

  3. 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.

  4. Time Missed From Work

    Time frame: 12 days

  5. Number of Participants With Reported Side Effects

    Time frame: 12 days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Washington University Pediatric and Adolescent Ambulatory Research Consortium

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 5, 2010
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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