Cerebral Palsy Clinical Trial
Official title:
A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
Verified date | August 2015 |
Source | Hill-Rom |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.
Status | Completed |
Enrollment | 29 |
Est. completion date | July 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Months to 18 Years |
Eligibility |
Inclusion Criteria: - Subject is at least 18 months old. - Subject has a chest circumference of greater than 19 inches. - Subject has a diagnosis of muscle weakness and restrictive lung disease. - Ability to provide Informed consent from legal guardian. - Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months - If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment Exclusion Criteria: - Subject has a diagnosed allergy with a respiratory trigger. - Participation in another clinical trial. - Unstable head or spinal injury. - Unresolved pneumothorax or pneumomediastinum present - Unresolved hemorrhage - Hypotension requiring vasopressors or positioning - Bronchopleural fistula - Gross hemoptysis within the past eight hours - Pulmonary embolism or history of pulmonary embolism within the past two months - Burns, open wounds and skin infections on the thorax - Osteomyelitis of the ribs - Osteoporosis with history of fractures. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Hill-Rom |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalizations Lasting at Least 24 Hours in This Patient Population | Hospitalizations lasting at least 24 hours | end of study | No |
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