Status:
COMPLETED
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Lead Sponsor:
Gabi SmartCare
Conditions:
Cardiac Disease
Respiratory Disease
Eligibility:
All Genders
Up to 5 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05319236
Start Date
February 16 2022
End Date
June 30 2023
Last Update
September 13 2023
Active Locations (4)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
3
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Belgium, 2610
4
Clinique CHC Montlégia
Liège, Belgium