Croup Clinical Trial
Official title:
Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
Verified date | July 2013 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).
Status | Completed |
Enrollment | 129 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 10 Years |
Eligibility |
Inclusion Criteria: - children aged 3 months - 10 years - croup score greater than or equal to 2 after a 30 minute waiting period Exclusion Criteria: - Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation - symptoms or signs of alternative causes of stridor - inability of caregivers to understand or speak English and/or sign for informed consent - history of chronic pulmonary disease except for asthma, or co-existent systemic disease - previous history of intubation - duration of present illness >1 week - systemic or inhaled glucocorticoids in previous 48 hours - epinephrine in previous 4 hours |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | The Physicians' Services Incorporated Foundation |
Canada,
Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in the croup score from baseline to 30 and 60 minutes | |||
Secondary | steroid or epinephrine treatment at 60 minutes | |||
Secondary | discharge rate at 60 minutes | |||
Secondary | change in pulse, respiratory rate, and oxygen saturation at 60 minutes |
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