Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pneuRIP
Sponsored by
About this trial
This is an interventional screening trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria: Subjects should have cerebral palsy a GMFCS levels IV, V Exclusion Criteria: -
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cerebral palsy group
Arm Description
Respiratory sensor will measure breathing in patients with Cerebral palsy
Outcomes
Primary Outcome Measures
Presence of pulmonary dysfunction
The presence of pulmonary dysfunction will be recorded for each subject. Presence will be determined clinically by the physician. Pulmonary dysfunction can take the form of pneumonia, ineffective airway clearance or atelectasis.
Secondary Outcome Measures
Full Information
NCT ID
NCT05791877
First Posted
March 9, 2023
Last Updated
September 26, 2023
Sponsor
Nemours Children's Clinic
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05791877
Brief Title
Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
Official Title
Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.
Detailed Description
This project proposes the utilization of a novel non-invasive real-time breathing sensor - pneuRIP- to measure pulmonary function (PF) in children with high-level cerebral palsy. Currently the standard measures of PF such as spirometry and peak flow meters are too strenuous for children and those with severe CP, as a result they have low compliance rates. The pneuRIP does not require active user participation and can passively measure PF. It consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. The pneuRIP yields indices of work of breathing (WOB) which includes the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.
The WOB indices provide a screening tool for pulmonary diagnosis and treatment, decrease the risk for pneumonia and respiratory illness, and has the potential to act as a marker for scoliosis in children with high-level CP.
The impact on the field will be to have a simple and fast way to measure pulmonary function in children and adults with severe CP and correlate this to measures of function and scoliosis severity as the effects of scoliosis, which is common in CP, on pulmonary function is unclear. Measures of motor function are classified by the Gross Motor Functional Classification System (GMFCS), ranking from I to V, with worsening disability from near normal gait in Type I to complete wheelchair use in Type V. This project will address GMFCS levels IV and V which includes people using wheelchairs. The two specific aims are a) Measure WOB indices non-invasively using the pneuRIP sensor in children with CP who use a wheelchair (GMFCS level IV, V) and validate the use of WOB indices as a screening test for pulmonary dysfunction., 2) Determine the correlation between WOB indices and the degree of scoliosis using the pneuRIP sensor in 250 children with CP who use a wheelchair (GMFCS level IV, V).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study with a single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cerebral palsy group
Arm Type
Experimental
Arm Description
Respiratory sensor will measure breathing in patients with Cerebral palsy
Intervention Type
Device
Intervention Name(s)
pneuRIP
Intervention Description
Respiratory sensor to measure pulmonary function
Primary Outcome Measure Information:
Title
Presence of pulmonary dysfunction
Description
The presence of pulmonary dysfunction will be recorded for each subject. Presence will be determined clinically by the physician. Pulmonary dysfunction can take the form of pneumonia, ineffective airway clearance or atelectasis.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects should have cerebral palsy a GMFCS levels IV, V
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tariq Rahman, PhD
Phone
6104539376
Email
trahman@nemours.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
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