Community Care for Croup (RCT)

The Washington University

Status and phase

Completed

Phase 4

Conditions

Croup

Treatments

Drug: Dexamethasone

Drug: Prednisone

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT01042145

09-0542

NIH/NCRR UL1RR024992

Details and patient eligibility

About

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.

Enrollment

87 patients

Sex

All

Ages

1 to 8 years old

Volunteers

No Healthy Volunteers

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.