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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device called JessieHug, designed to monitor the health of newborns and infants. The researchers aim to determine if parents find the device easy to use, if it is comfortable and safe for babies, and if it collects accurate health data. Parents will attach the device to their baby twice a week and complete surveys about their experience. The trial seeks healthy babies born after a full-term pregnancy who have not required special medical care after birth. This study involves babies in three age groups: newborns, 2-month-olds, and 4-month-olds. As an unphased study, this trial allows parents to contribute to the development of innovative health monitoring technology for infants.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on using a wearable device for infants, so it seems unlikely that your medications would be affected.

What prior data suggests that the JessieHug device is safe for infants?

Research shows that the JessieHug device is designed to be safe and comfortable for babies. Studies have found that infants can wear the device twice a week without issues. Past tests reported no major safety concerns. The primary goal has been to ensure the device doesn't cause discomfort and remains easy for parents to use. Although detailed safety data from past studies isn't available, the emphasis on user-friendliness and safety suggests a careful approach to protecting babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the JessieHug device because it offers a new, non-invasive approach to addressing Sudden Infant Death Syndrome (SIDS), a condition where traditional methods focus more on prevention through lifestyle changes and monitoring. Unlike existing options, JessieHug is a wearable device that aims to assess and ensure infant safety by being placed on infants twice a week, focusing on usability, tolerability, and safety. This device could potentially provide real-time insights and interventions, which is a significant advancement over current methods that do not offer direct interaction with the infant's environment.

What evidence suggests that the JessieHug device is effective for Sudden Infant Death Syndrome?

Research has shown that wearable devices like JessieHug can track vital signs in babies to help identify potential risks, such as Sudden Infant Death Syndrome (SIDS). Early results suggest that monitoring these health signs could be crucial for detecting problems before they become serious. In this trial, researchers will place the JessieHug device on infants in different age cohorts to assess its usability, tolerability, and safety. The device aims to gather accurate data for comparison with FDA-approved devices, ensuring reliability. Although specific data on JessieHug's effectiveness in preventing SIDS is not yet available, the goal is to collect clear and helpful information to assist parents and doctors in better protecting infants. ^{2 5 6 7 8}

Who Is on the Research Team?

James M Kim, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/jessiehug-for-sudden-infant-death-syndrome-fe61f

JessieHug for Sudden Infant Death Syndrome The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10351748/

Sudden Infant Death Syndrome: Risk Factors and Newer Risk ... Sudden Infant Death Syndrome (SIDS) accounts for about 38.4 deaths per 100,000 live births (approximately 1,389 deaths) as per records of the ...

3. youtube.com youtube.com/watch?v=b3bCKbVdmqQ

Sydney researchers make 'world-first breakthrough' in ... Sydney researchers have made a world-first breakthrough to identify babies more at risk of Sudden Infant Death Syndrome (SIDS) while they're ...

4. cdc.gov cdc.gov/sudden-infant-death/data-research/data/index.html

Data and Statistics for SUID and SIDS Find links to sudden unexpected infant death (SUID) data by cause of death, trends in SUID, SUID rates by state, and SUID rates by race and ethnicity.

5. youtube.com youtube.com/watch?v=ys0FI1yLOCA

Confronting Claims About The Latest SIDS Research (Media ... The research has concluded that the enzyme bhce could actually be a potential biomarker to help identify newborn babies who are at risk of sids.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06466148

JessieHug Feasibility and Usability Assessment 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 ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK513399/

Sudden Infant Death Syndrome: An Overview - NCBI - NIH SIDS refers to death in a seemingly healthy infant younger than 1 year of age whose death remains unexplained after a thorough case investigation.

8. malacards.org malacards.org/card/sudden_infant_death_syndrome

Sudden Infant Death Syndrome (SIDS) Integrated disease information for Sudden Infant Death Syndrome including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated ...