Clinical trial NCT05319236: Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Respiratory Disease
Congenital Cardiac Defect
Cardiovascular Diseases
Chronic Respiratory Disease
Chronic Cardiopulmonary Disease
Premature Infant Disease
Lead sponsor: Gabi SmartCare
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 101
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Utility
timeFrame: Assessed at the end of the 3-month period for each participant
measure: Caregiver Usability
timeFrame: Assessed at the end of the 3-month period for each participant
measure: HCP Usability
timeFrame: Assessed at the end of the 3-month period for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
city: Liège
country: Belgium
facility: Clinique CHC Montlégia
Study officials:
References: