Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)

NCT05319236 | Completed

• 1 other identifier: R-DND-11 BRIDGE Study_CIP
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 4

Brief Summary

Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject. The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children \< 6 years old with underlying medical conditions. This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system. The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers. \*During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.

Conditions

Cardiac Disease; Respiratory Disease; Congenital Cardiac Defect; Cardiovascular Diseases; Chronic Respiratory Disease; Chronic Cardiopulmonary Disease; Premature Infant Disease

Outcome Measures

Primary Outcomes (3)

• Clinical Utility

  Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.

  Assessed at the end of the 3-month period for each participant

• Caregiver Usability

  Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.

  Assessed at the end of the 3-month period for each participant

• HCP Usability

  Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.

  Assessed at the end of the 3-month period for each participant

Study Arms (1)

Gabi System

OTHER

Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.

Device: Gabi System

Interventions

Gabi System DEVICE

See arm description

Gabi System

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants and children \< 6 years old.
• Subjects who present at least one of the following underlying medical conditions:
• Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently and could benefit from an additional post-surgery monitoring at home, per the investigator's opinion.
• Subjects at risk awaiting surgery.
• Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy.
• Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia.
• Subjects with chronic respiratory disease, such as asthma, developmental or cardiovascular conditions who could benefit from medical monitoring at home, per the investigator's opinion.
• Subjects with chronic respiratory support at home.
• Premature babies who required intensive neonatal care.
• Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks.
• A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject
• Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study.
• Signed informed consent form prior to performing any study specific procedure.
• Willing and likely (based on the investigator's judgement) to comply with all study requirements.

You may not qualify if:

• Weight \< 2.5 kg.
• Subject presenting an anatomical limitation that would prevent the use of the Gabi system.
• Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ).
• Subjects participating in another interventional clinical study (with the exception of registries), which may have an impact on this study outcomes, based on the investigator's judgement.

Sponsors & Collaborators

• Gabi SmartCare: lead

Study Sites (4)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Universitair Ziekenhuis Antwerpen (UZA)

Antwerp, 2610, Belgium

Location

Clinique CHC Montlégia

Liège, Belgium

Location

MeSH Terms

Conditions

Heart Diseases; Respiration Disorders; Heart Defects, Congenital; Cardiovascular Diseases; Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: February 16, 2022
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); US (2)