Comparing Different Ways of Delivering Humidity to Children With Croup

This study has been completed.

Sponsors and Collaborators:	The Hospital for Sick Children Physicians Services Incorporated (PSI)
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00230841

Purpose

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).

Condition	Intervention	Phase
Croup	Device: nebulized humidity	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

changes in the croup score from baseline to 30 and 60 minutes

Secondary Outcome Measures:

steroid or epinephrine treatment at 60 minutes
discharge rate at 60 minutes
change in pulse, respiratory rate, and oxygen saturation at 60 minutes

Estimated Enrollment:	129
Study Start Date:	September 2001
Estimated Study Completion Date:	April 2004

Eligibility

Ages Eligible for Study:	3 Months to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230841

Locations

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Physicians Services Incorporated (PSI)

Investigators

Principal Investigator:

Dennis Scolnik, MD

The Hospital for Sick Children, Toronto Canada

More Information

Publications of Results:

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.

Study ID Numbers:	0020010158
Study First Received:	September 29, 2005
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00230841
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

croup
humidity therapy
pediatrics

Study placed in the following topic categories:

Croup
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Laryngitis
Laryngeal Diseases

ClinicalTrials.gov processed this record on January 16, 2009