JessieHug Feasibility and Usability Assessment

Description

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.

Conditions

SIDS

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Study Overview

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Study Details

Study overview

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.

JessieHug Feasibility and Usability Assessment

JessieHug Feasibility and Usability Assessment

Condition
SIDS
Intervention / Treatment

-

Contacts and Locations

New York

NewYork Presbyterian - Weill Cornell Medical Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Healthy neonates and infants, with cohorts defined by the following age ranges:
  • 1. newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days),
  • 2. 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days),
  • 3. 4-month (14 weeks and 0/7 days to 19 weeks and 6/7 days)
  • 2. Born after 37 0/7 weeks of pregnancy
  • 3. Parent or legal guardian at time of discharge is able to understand and provide consent for participation
  • 4. Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study
  • 5. Parent or legal guardian is fluent in English
  • 6. Parent or legal guardian has access to the internet
  • 1. Low birth weight (\< 2500g)
  • 2. Any transfer out of the well baby nursery for increased level of care, including admission to the NICU or transitional nursery.
  • 3. Clinical indication for prolonged postnatal hospitalization (\>4 days)

Ages Eligible for Study

0 Months to 4 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Weill Medical College of Cornell University,

James M Kim, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2026-07-01