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Low patient accrual.
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| Name | Class |
|---|---|
| Empatica, Inc. | INDUSTRY |
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The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data. The main questions it aims to answer are:
Participants will:
This study evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that continuously collects physiological data. Three cohorts of infants will be enrolled: newborn, 2-month, and 4-month groups, with each cohort undergoing data collection over a total of eight (8) weeks. The JessieHug device will be assessed for usability and tolerability through parental surveys while the baby wears the device in home and hospital settings. Clinical accuracy of the device will be evaluated through comparison to an FDA cleared reference device in a single outpatient clinic-based data collection event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newborn Cohort | Experimental | The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session. |
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| 2 month Cohort | Experimental | The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session. |
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| 4 month Cohort | Experimental | The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JessieHug | Device | Assessment of JessieHug device when placed on infants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluating usability of the JessieHug measured by a System Usability Survey | Usability as measured by an average score of at least 68 out of 100 on the System Usability Survey (Lewis & Sauro, 2018). Lowest possible score is 0 indicating low usability and highest possible score is 100 indicating high usability. Usability surveys will include questions related to ease of use, satisfaction, and confidence when interacting with the device. | Every other week for through study completion (8 weeks) |
| Evaluating tolerability of the JessieHug measured by the Face, Legs, Activity, Cry, and Consolability Scale (FLACC) survey, which is an observer reported outcomes (ObsRO) survey. | Tolerability as defined as a score of 5 or less on the FLACC. Lowest possible score is 0 indicating no pain and highest possible score is 10 indicating severe pain. The FLACC scale is a behavioral pain assessment scale, validated for use in children from 2 months to 7 years of age, that is used to assess pain in children who are unable to communicate their pain verbally (Voepel-Lewis et al., 1997). | Every week for through study completion (8 weeks) |
| Evaluating safety of the JessieHug assessed through a survey assessing adverse events and pain. | The qualitative safety questionnaire assesses overall tolerability of the device, satisfaction of the caregiver for the tolerability of the device, pain or adverse reactions experienced, persistence of symptoms, and the degree any potential pain or adverse reactions interfered with daily activities or sleep. | Every week for through study completion (8 weeks) |
| Percent caregiver completing all steps without errors | Ability of caregivers to follow provided instructions for unpacking and setting up the JessieHug device. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Validating the clinical accuracy of the physiological parameters measured by the JessieHug (SpO2) against FDA-cleared reference devices. | Accuracy of the SpO2 algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3.5% during no-motion conditions, respectively. |
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Inclusion Criteria:
Healthy neonates and infants, with cohorts defined by the following age ranges:
Born after 37 0/7 weeks of pregnancy
Parent or legal guardian at time of discharge is able to understand and provide consent for participation
Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study
Parent or legal guardian is fluent in English
Parent or legal guardian has access to the internet
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Kim, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork Presbyterian - Weill Cornell Medical Center | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| One session, up to 4 hours, during study period, up to 8 weeks. |
| Validating the clinical accuracy of the physiological parameters measured by the JessieHug (pulse rate) against FDA-cleared reference devices. | Accuracy of the pulse rate algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3 beats per minute (bpm)during no-motion conditions, respectively . | One session, up to 4 hours, during study period, up to 8 weeks. |
| Validating the clinical accuracy of the physiological parameters measured by the JessieHug (respiratory rate) against FDA-cleared reference devices. | Accuracy of the respiratory rate algorithm outputs derived from JessieHug sensor data as measured by the Accuracy root-mean-square (Arms) difference between the JessieHug device measurements and the reference device measurements with passing criteria of 3 breaths per minute (brpm) no-motion conditions, respectively. | One session, up to 4 hours, during study period, up to 8 weeks. |
| D066088 |
| Infant Death |