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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabi System | Device | See arm description |
|
| 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 |
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Inclusion Criteria:
Infants and children < 6 years old.
Subjects who present at least one of the following underlying medical conditions:
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 Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States | ||
| Columbia University Irving Medical Center |
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| New York |
| New York |
| 10032 |
| United States |
| Universitair Ziekenhuis Antwerpen (UZA) | Antwerp | 2610 | Belgium |
| Clinique CHC Montlégia | Liège | Belgium |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D012120 | Respiration Disorders |
| D006330 | Heart Defects, Congenital |
| D002318 | Cardiovascular Diseases |
| D011660 | Pulmonary Heart Disease |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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