NCT05791877

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2023Nov 2026

First Submitted

Initial submission to the registry

March 9, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

March 9, 2023

Last Update Submit

November 19, 2025

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (1)

cerebral palsy group

EXPERIMENTAL

Respiratory sensor will measure breathing in patients with Cerebral palsy

Device: pneuRIP

Interventions

pneuRIPDEVICE

Respiratory sensor to measure pulmonary function

cerebral palsy group

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects should have cerebral palsy a GMFCS levels IV, V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Hospital

Wilmington, Delaware, 19833, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tariq Rahman, PhD

    Principal Research Engineer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tariq Rahman, PhD

CONTACT

6104539376trahman@nemours.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Prospective observational study with a single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Engineer

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 30, 2023

Study Start

October 2, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)