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Comparing Different Ways of Delivering Humidity to Children With Croup

NCT ID: NCT00230841

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Croup

Keywords

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croup humidity therapy pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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nebulized humidity

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Dennis Scolnik

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Scolnik, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 16537737 (View on PubMed)

Other Identifiers

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0020010158

Identifier Type: -

Identifier Source: org_study_id