HFCWO in Hospitalized Asthmatic Children - Tabular View

Tracking Information
First Received Date ^ICMJE	July 23, 2008
Last Updated Date	July 24, 2008
Start Date ^ICMJE	July 2008
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2008)	The primary endpoint will be time to readiness for discharge. [ Time Frame: Hospital days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00722020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2008)	Secondary endpoint total length of hospital stay. [ Time Frame: Days ] [ Designated as safety issue: No ] Duration and number of doses of bronchodilator therapy [ Time Frame: Day ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	HFCWO in Hospitalized Asthmatic Children
Official Title ^ICMJE	High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
Brief Summary	To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition ^ICMJE	Bronchial Asthma Asthma Status Asthmaticus
Intervention ^ICMJE	Device: High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)) Device: Regular nebulized bronchodilator treatment.
Study Arms / Comparison Groups	Active Comparator: Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Sham Comparator: Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	220
Estimated Completion Date	July 2009
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease Exclusion Criteria: Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis) Those who regularly use HFCWO Any patient exhibiting an absolute contraindication to HFCWO therapy Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
Gender	Both
Ages	18 Months to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00722020
Responsible Party	Jon Roberts MD, PI, Winthrop Pediatric Associates
Study ID Numbers ^ICMJE	CR-0078
Study Sponsor ^ICMJE	Hill-Rom
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hill-Rom
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP