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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device that monitors vital signs such as heart rate and breathing in infants. The goal is to evaluate the device's effectiveness in real-life hospital settings with infants in the newborn nursery or specific pediatric care units. Parents with a baby in the hospital can participate by signing a consent form to try the device. This research could enhance future infant health monitoring. As an unphased trial, it offers parents a unique opportunity to contribute to advancements in infant healthcare technology.

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 prior data suggests that this wearable vital signs monitoring device is safe for infants?

Research shows that wearable sensor technologies are becoming important in newborn care. These devices monitor key signs like heart rate and breathing. Studies have found that parents generally feel satisfied with these devices and believe they help track their babies' health.

The information provided does not include specific reports of safety issues or negative effects. As this study focuses on feasibility, the research is in its early stages. Early research often emphasizes ease of use rather than long-term safety, so detailed safety information might not yet be available.

Overall, the wearable device appears well-received and offers a modern way to monitor babies' vital signs. However, because this technology is still new, further studies might be needed to fully understand its safety for infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the investigational wearable vital signs monitoring device for infants because it offers real-time health monitoring in a non-invasive way. Unlike traditional methods that might require hospital visits or bulky equipment, this wearable device can continuously track vital signs like heart rate and temperature from the comfort of home. This can lead to quicker detection of potential health issues, allowing for timely interventions and reducing the stress on both infants and their caregivers.

What evidence suggests that this wearable vital signs monitoring device is effective for infant health monitoring?

Research has shown that wearable devices can track important health information in babies, particularly for monitoring heart health. One study found that parents were generally satisfied with these devices, appreciating their benefits in monitoring their baby's health. These wearables collect data such as heart rate and breathing patterns, which can be crucial for babies with health issues. In this trial, participants will use the Investigational Wearable Vital Signs Monitoring Device, which remains under testing. Early signs suggest it could be a helpful tool for parents and doctors to better monitor a baby's health. ^{2 4 6 7 8}

Who Is on the Research Team?

Danielle Gottlieb Sen, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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

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

Parent provided written informed consent

Exclusion Criteria

Foster or ward of the state

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05910320

Evaluation of an Investigational Wearable Vital Signs ... The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants. Detailed ...

2. trialx.com trialx.com/clinical-trials/listings/275099/evaluation-of-an-investigational-wearable-vital-signs-monitoring-device-in-healthy-infants/

Evaluation of an Investigational Wearable Vital Signs ... The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in ...

3. withpower.com withpower.com/trial/phase-heart-diseases-4-2023-46f35

Wearable Vital Signs Monitor for Infant Health Monitoring 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12337009/

Parental perceptions of a wearable vital signs monitor for ... This study explored the acceptability, satisfaction, and perceived benefits of the neoGuard wearable vital signs monitoring device among parents ...

5. jelsciences.com jelsciences.com/abstracts/1775

Noninvasive Vital Signs Monitoring in the Neonatal ... Abstract. Patients in the Neonatal Intensive Care Unit (NICU) have high mortality and morbidity rates due to their low birth weight or being preterm.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528303/

Emerging innovations in neonatal monitoring - PubMed Central Wearable sensor technologies play a crucial role in modern neonatal care, providing continuous monitoring of heart rate (HR), respiratory rate ( ...

7. link.springer.com link.springer.com/article/10.1007/s12098-023-04791-7

Wearables – A Revolution in Neonatal Monitoring? A wearable device that monitors the vital signs of the neonate and transmits real-time data from the infant's body to a central monitoring station.

8. nature.com nature.com/articles/s43246-024-00511-6

Skin-interfacing wearable biosensors for smart health ... This paper summarizes the latest advancements in neonatal wearable systems and the different approaches to each branch of physiological monitoring.