Community Care for Croup (RCT)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Croup

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Prednisone

Prednisone, 2mg/kg for 3 days

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

2 mgs/kg for 3 days

Dexamethasone

Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

0.6 mgs for one day, then placebo for 2 days

Interventions

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Prednisone

2 mgs/kg for 3 days

Intervention Type DRUG

Dexamethasone

0.6 mgs for one day, then placebo for 2 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No