Wearable Vital Signs Monitor for Infant Health Monitoring

Overseen By Kate Calligy, BSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Foster or ward of state

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

45 Participants Needed

Trial Summary

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}

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.

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

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

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

Investigational Wearable Vital Signs Monitoring Device is already approved in United States for the following indications:

Approved in United States as Anne One for:

• Heart rate monitoring
• Respiratory rate monitoring
• Skin temperature monitoring
• Body temperature monitoring
• Apnea-hypopnea index monitoring
• Total sleep time monitoring
• Snoring monitoring
• Chest wall movement monitoring
• Body position monitoring
• Pulse rate monitoring
• Peripheral arterial tonometry monitoring
• SpO2 monitoring

Approved in United States as Gabi SmartCare for:

• Oxygen saturation monitoring
• Heart rate monitoring
• Movement monitoring

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

A study involving 21 pediatric patients showed that a multi-sensor wearable device for monitoring vital signs was well-accepted and feasible for use by healthcare workers, parents, and children during hospitalization.

The device reliably measured heart rate and oxygen saturation compared to conventional methods, but it underestimated body temperature, highlighting the need for further validation of wearable devices in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Technologies for Pediatric Patients with Surgical Infections-More than Counting Steps? Mack, I., Juchler, N., Rey, S., et al.[2022]

The Nemocare Raksha (NR) device successfully monitored vital signs in 40 newborns for 6 hours without causing any discomfort or adverse events, indicating its safety for use in this population.

The NR device showed good agreement with standard monitoring devices for heart rate and oxygen saturation, but moderate to poor agreement for body temperature and respiratory rate, suggesting it is reliable for certain vital signs but may need further refinement for others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Wireless Device for Monitoring Vitals in Newborn Babies. Aggarwal, R., Gunaseelan, V., Manual, D., et al.[2023]

In a study of 100 low-risk newborns, the IntelliVue system measured heart rate (HR) significantly faster than the Nellcor pulse oximeter, with a median time of 24 seconds compared to 48 seconds (p<0.001).

The IntelliVue system also detected initial bradycardia more frequently (55% of cases) than the Nellcor system (6%), suggesting it may provide more immediate insights into the infants' heart conditions.

NCBI (Pubmed)

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. Murphy, MC., De Angelis, L., McCarthy, LK., et al.[2019]

Wearable Health Devices (WHDs) are becoming essential tools for both personal health monitoring and providing clinicians with valuable data, potentially leading to earlier diagnoses and better treatment guidance.

The review highlights various vital signs that WHDs can monitor, such as heart rate and blood pressure, and discusses their significance for health assessment, showcasing advancements in technology that enhance the reliability and adaptability of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Health Devices-Vital Sign Monitoring, Systems and Technologies. Dias, D., Paulo Silva Cunha, J.[2023]

In a study involving 4769 patient admissions, continuous vital sign monitoring using wearable devices linked to hospital systems significantly reduced unplanned ICU admissions from 3.4% to 2.3% and rapid response team calls from 4.3% to 3.1%.

While the wearable monitoring improved early detection of patient deterioration, it did not significantly affect the length of hospital stay or in-patient death rates, indicating a need for further research on its impact on overall patient survival.

NCBI (Pubmed)

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. Eddahchouri, Y., Peelen, RV., Koeneman, M., et al.[2022]

A systematic review of 427 studies identified only seven observational studies that met the criteria for examining patient acceptability of wearable vital sign monitoring devices in hospitals, highlighting a significant gap in high-quality research on this topic.

Most patients reported positive experiences and satisfaction with the wearable devices, indicating a general acceptability, although the overall quality of the studies was low and findings were mixed in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient acceptability of wearable vital sign monitoring technologies in the acute care setting: A systematic review. Sprogis, SK., Currey, J., Considine, J.[2019]

The newly developed BBA bootee for infants allows for wireless monitoring of pulse oximetry and movement, showing a small bias in SpO2 and heart rate measurements compared to reference monitors, indicating its potential accuracy.

An integrated algorithm helps reduce false alarms caused by motion artifacts during monitoring, enhancing the reliability of the system for tracking infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance of infants at risk of apparent life threatening events (ALTE) with the BBA bootee: a wearable multiparameter monitor. Rimet, Y., Brusquet, Y., Ronayette, D., et al.[2020]

In a review of seven studies involving 1485 patients, continuous wireless monitoring systems (CWMS) showed a low frequency of adverse device effects (ADEs) at 3.6%, with no unanticipated serious adverse device effects (USADEs) or serious adverse device effects (SADEs) reported, indicating a strong safety profile.

The study highlights that while CWMS are generally safe, there is a need for systematic reporting of all adverse effects to better understand their impact in clinical settings.

NCBI (Pubmed)

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. Aagaard, N., Larsen, AT., Aasvang, EK., et al.[2023]

Wearable sensor systems for infants can continuously monitor their health by tracking physiological parameters and transmitting this information to parents or clinicians, enhancing safety and care.

These systems are also capable of detecting external threats like falling or drowning, providing immediate alerts to parents, which could significantly improve infant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable sensor systems for infants. Zhu, Z., Liu, T., Li, G., et al.[2022]

A new miniaturized, wireless temperature sensor has been developed for monitoring body temperature in vulnerable populations, such as premature infants in incubators, achieving accuracy within 0.05 °C compared to traditional wired sensors.

This innovative device not only measures temperature but also supports continuous monitoring of other vital signs, making it useful for various medical applications, including sepsis detection and assessments of tissue health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple, miniaturized biosensors for wireless mapping of thermoregulatory responses. Oh, S., Yoo, JY., Maeng, WY., et al.[2023]

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]