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Comparing Different Ways of Delivering Humidity to Children With Croup

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00230841
First received: September 29, 2005
Last updated: October 10, 2006
Last verified: September 2005
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Dennis Scolnik, MD The Hospital for Sick Children, Toronto Canada
  More Information

Publications:

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

Keywords provided by The Hospital for Sick Children:
croup
humidity therapy
pediatrics

Additional relevant MeSH terms:
Croup
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013