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

A Prospective, Multicentric Interventional Study Assessing the Range of Most Clinically Relevant Indications for Use of the Non-invasive Wireless Gabi System for the Recording, in Non-motion Condition, of SpO2, Pulse Rate, Respiratory Rate and Movements of Young Children With Underlying Medical Conditions.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Respiratory Disease; Cardiac Disease; Congenital Cardiac Defect; Premature Infant Disease; Chronic Respiratory Disease; Chronic Cardiopulmonary Disease
• Intervention / Treatment: Device: Gabi System

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edouard Carton; Phone Number: +32 472 53 78 41; Email: edouard.carton@gabismartcare.com

Study Locations

• Belgium
  • Antwerp, Belgium, 2610
    • Universitair Ziekenhuis Antwerpen (Uza)
  • Liège, Belgium
    • Clinique CHC MontLégia
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Infants and children < 6 years old.

2. Subjects who present at least one of the following underlying medical conditions:

   1. 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.
   2. Subjects at risk awaiting surgery.
   3. Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy.
   4. Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia.
   5. 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.
   6. Subjects with chronic respiratory support at home.
   7. Premature babies who required intensive neonatal care.
   8. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks.
   9. A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject
3. Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study.
4. Signed informed consent form prior to performing any study specific procedure.
5. Willing and likely (based on the investigator's judgement) to comply with all study requirements.

Exclusion Criteria:

1. Weight < 2.5 kg.
2. Subject presenting an anatomical limitation that would prevent the use of the Gabi system.
3. Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ).
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gabi System; 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; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gabi SmartCare

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Infant, Newborn, Diseases; Cardiovascular Abnormalities; Heart Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Heart Defects, Congenital; Pulmonary Heart Disease; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: R-DND-11 BRIDGE Study_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No