JessieHug for Sudden Infant Death Syndrome

Overseen By Martha Liu, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Low birth weight, NICU admission, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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: * Is the device easily usable for parents of newborns and infants? * Is the device tolerable when worn by infants and are there any safety concerns? * Is the device able to collect clinically accurate physiologic data compared to a FDA-cleared reference device? Participants will: * Place the JessieHug device on their infant two times a week and complete surveys to assess usability, tolerability and safety. * Have one session where the JessieHug device will be worn at the same time as reference device to determine accuracy.

Research Team

James M Kim, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for parents or guardians of newborns and infants born after a full-term pregnancy, who can understand English, provide consent, and commit to the study's duration. They must have internet access to participate in surveys about their infant wearing the JessieHug device.

Inclusion Criteria

I am between 6 weeks and 11 weeks pregnant.

I am between 14 and 20 weeks pregnant.

My parent or guardian can understand and agree to the study on my behalf.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the JessieHug device on their infants two times a week and complete surveys to assess usability, tolerability, and safety.

8 weeks

Weekly in-home sessions, one outpatient clinic session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JessieHug

Trial Overview The JessieHug clinical trial tests a wearable device for infants that monitors physiological data. It checks if the device is user-friendly for parents, safe and comfortable for infants, and if it accurately measures health data compared to an FDA-approved reference.

Participant Groups

Group I: Newborn Cohort Experimental Treatment 1 Intervention

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.

Group II: 4 month Cohort Experimental Treatment 1 Intervention

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.

Group III: 2 month Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Empatica, Inc.

Industry Sponsor

Trials

7

Recruited

104,000+