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 (Responsible Party):
Dennis Scolnik, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00230841
First received: September 29, 2005
Last updated: July 31, 2013
Last verified: July 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Dennis Scolnik, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00230841     History of Changes
Other Study ID Numbers: 0020010158
Study First Received: September 29, 2005
Last Updated: July 31, 2013
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 July 20, 2014