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Comparing Different Ways of Delivering Humidity to Children With Croup

Primary Purpose

Croup

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
nebulized humidity
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Croup focused on measuring croup, humidity therapy, pediatrics

Eligibility Criteria

3 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Outcomes

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

Full Information

First Posted
September 29, 2005
Last Updated
July 31, 2013
Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00230841
Brief Title
Comparing Different Ways of Delivering Humidity to Children With Croup
Official Title
Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Croup
Keywords
croup, humidity therapy, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
129 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
nebulized humidity
Primary Outcome Measure Information:
Title
changes in the croup score from baseline to 30 and 60 minutes
Secondary Outcome Measure Information:
Title
steroid or epinephrine treatment at 60 minutes
Title
discharge rate at 60 minutes
Title
change in pulse, respiratory rate, and oxygen saturation at 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Scolnik, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16537737
Citation
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. doi: 10.1001/jama.295.11.1274.
Results Reference
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Comparing Different Ways of Delivering Humidity to Children With Croup

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