Comparing Different Ways of Delivering Humidity to Children With Croup

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT00230841
Collaborator
The Physicians' Services Incorporated Foundation (Other)
129
1
31
4.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: nebulized humidity
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
Study Start Date :
Sep 1, 2001
Study Completion Date :
Apr 1, 2004

Outcome Measures

Primary Outcome Measures

  1. changes in the croup score from baseline to 30 and 60 minutes []

Secondary Outcome Measures

  1. steroid or epinephrine treatment at 60 minutes []

  2. discharge rate at 60 minutes []

  3. change in pulse, respiratory rate, and oxygen saturation at 60 minutes []

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dennis Scolnik, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00230841
Other Study ID Numbers:
  • 0020010158
First Posted:
Oct 3, 2005
Last Update Posted:
Aug 2, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Dennis Scolnik, Staff Physician, The Hospital for Sick Children
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2013