Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children

NCT04886583 — Completed, 99 participants, Gabi SmartCare

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Preliminary Multi-centric Clinical Study Assessing the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for the Continuous Monitoring and Recording of Vital Physiological Parameters on Infants and Young Children by Comparison of Simultaneous Polysomnographic Recording During Standard of Care Hospitalisation

Registry	NCT04886583, acronym WAGSC1
Status	Completed
Study type	Observational
Enrollment	99 (Actual)
Sponsor	Gabi SmartCare (Industry)
Conditions	Blood Oxygen Desaturations, Sleep-Disordered Breathing
Interventions	Gabi Baby Band (Device)
Dates	start 2021-04-30, primary completion 2022-02-28, completion 2022-02-28, first posted 2021-05-14, last updated 2022-04-04
Locations	3 sites in Belgium

-Summary

During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep. After the test, data from the device and from the PSG (HR, SpO2, BR) will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values (ECG, Oximeter, belly belt). In a second analysis, the aim is to improve the accuracy of the GBB algorithm.

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+Arms and interventions

Arm	Type	Interventions	Description
Gabi Baby Band		Device: Gabi Baby Band	GSC 1

Gabi Baby Band (Device): Every enrolled patient must wear the Gaby Baby Band on the left arm in the aim to perform data analytics after the test has been performed

+Outcome measures

Primary outcomes

to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB [12 hours]: The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring SpO2 (%) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.

Secondary outcomes

to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB [12 hours]: The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring BR (breathing rate; cycle/min) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.
to improve the calibration, the correctness and reproducibility of the measurements of the HR (heart rate; beat/min or bpm) reported by the GBB [12 hours]: The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring BR (heart rate; beat/min) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.

+Eligibility

Sex: All, ages: any to 5 Years, accepts healthy volunteers

Inclusion Criteria:

* Infants and children under 5 years of age
* PSG is required per standard of care
* Signature of consent form

Exclusion Criteria:

* Children having already done the PSG wearing GBB for this study
* Epileptic children (due to high motion/artifacts during sleep)
* Weight below 2.5 kg

+Locations (3)

Facility	City	Country
Hopital Universitaire Des Enfants Reine Fabiola	Jette, Brussels Capital	Belgium
CHU Marie Curie	Charleroi, Hainaut	Belgium
CHC Montlégia	Liège	Belgium