Wearable Vital Signs Monitor for Infant Health Monitoring

Recruiting in Palo Alto (17 mi)

Overseen by Danielle Gottlieb Sen, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Foster or ward of state

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new wearable device that monitors vital signs in infants. It aims to help infants with heart conditions and healthy infants by providing continuous health data and alerts for any issues. The goal is to improve survival rates and overall health outcomes.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Investigational Wearable Vital Signs Monitoring Device for infant health monitoring?

Research shows that wearable devices can reliably measure vital signs like heart rate and oxygen levels in children, and they are well-accepted by healthcare workers and families. Continuous monitoring with these devices may help detect health issues early, potentially saving lives. ^{1 2 3 4 5}

Is the wearable vital signs monitor safe for infants?

Research shows that wearable devices for monitoring vital signs in infants are generally safe. Studies on similar devices have shown high acceptance and feasibility, with no serious adverse effects reported. ^{1 2 6 7 8}

How is the Investigational Wearable Vital Signs Monitoring Device different from other treatments for infant health monitoring?

The Investigational Wearable Vital Signs Monitoring Device is unique because it continuously monitors vital signs in infants using miniaturized, wireless sensors that can detect both internal physiological parameters and external threats like falling or drowning, providing real-time alerts to parents or clinicians. ^{1 4 6 9 10}

Research Team

Danielle Gottlieb Sen, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for infants with heart conditions who are in the newborn nursery, pediatric cardiac ICU, or pediatric care unit. Parents must consent to their child's participation. Infants under state guardianship (foster or ward) cannot participate.

Inclusion Criteria

Parent provided written informed consent

I am admitted to the newborn, pediatric cardiac ICU, or pediatric care unit.

Exclusion Criteria

Foster or ward of the state

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Placement and Monitoring

Participants are fitted with the wearable vital signs monitoring device to evaluate its feasibility

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device use

4 weeks

Treatment Details

Interventions

• Investigational Wearable Vital Signs Monitoring Device (Wearable Device)

Trial Overview The study is testing a new wearable device that monitors vital signs like heart rate and breathing in babies with heart disease to see if it works well and is easy to use.

Participant Groups

Group I: Wearable Vital Signs Monitoring Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Technologies for Pediatric Patients with Surgical Infections-More than Counting Steps? [2022]

2. India pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Wireless Device for Monitoring Vitals in Newborn Babies. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Randomised study comparing heart rate measurement in newly born infants using a monitor incorporating electrocardiogram and pulse oximeter versus pulse oximeter alone. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Health Devices-Vital Sign Monitoring, Systems and Technologies. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of continuous wireless vital sign monitoring on unplanned ICU admissions and rapid response team calls: a before-and-after study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Patient acceptability of wearable vital sign monitoring technologies in the acute care setting: A systematic review. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Surveillance of infants at risk of apparent life threatening events (ALTE) with the BBA bootee: a wearable multiparameter monitor. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards: a review of current evidence. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable sensor systems for infants. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Simple, miniaturized biosensors for wireless mapping of thermoregulatory responses. [2023]