RECRUITING

JessieHug Feasibility and Usability Assessment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

JessieHug Feasibility and Usability Assessment

Quick Facts

Study Start:2024-04-10
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06466148

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.

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

Contacts and Locations

Study Contact

James M Kim, MD
CONTACT
978-886-2791
jmk9018@med.cornell.edu
Martha Liu, MS
CONTACT
+1 646-962-4668
mal4038@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-10
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-04-10
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • medical device
  • wearable medical device
  • infants

Additional Relevant MeSH Terms

  • SIDS