Comparing Different Ways of Delivering Humidity to Childr... | NCT00230841

Studies
Comparing Different Ways of Delivering Humidity to Children With Croup

NCT00230841

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Aug 2, 2013Estimated

Enrollment

129

Phase

Phase 2

Conditions

Croup

Interventions

nebulized humidity

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Apr 2004

First Submitted Date

Sep 29, 2005

First Submission Date that Met QC Criteria

Sep 29, 2005

First Posted Date

Oct 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129

Name	Type	Description	Arm Group Labels	Other Names
nebulized humidity	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in the croup score from baseline to 30 and 60 minutes

Secondary Outcomes

Measure	Description	Time Frame
steroid or epinephrine treatment at 60 minutes
discharge rate at 60 minutes
change in pulse, respiratory rate, and oxygen saturation at 60 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis Scolnik, MD	The Hospital for Sick Children, Toronto Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16537737	Result	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.

ID	Term
D007827	Laryngitis
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases