Clinical trial NCT01042145: Community Care for Croup (RCT)
Official title: Community Care for Croup (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Croup
Keywords: Primary Care
Treatment
Croup
Corticosteroids
Prednisone
Dexamethasone
Randomized trial
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Washington University Pediatric and Adolescent Ambulatory Research Consortium
First posted: 2010-01-05
Enrollment: 87
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Additional Health Care
timeFrame: 11 days
Secondary outcomes:
measure: Duration of Croup Symptoms
timeFrame: 12 days
measure: Nights With Disturbed Sleep
timeFrame: 12 days
measure: Parental Stress
timeFrame: 12 days
measure: Time Missed From Work
timeFrame: 12 days
measure: Number of Participants With Reported Side Effects
timeFrame: 12 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jane M Garbutt, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3.