Wireless Sensors for Neonatal Care

(AWARD Trial)

Recruiting at 7 trial locations

Overseen By Melissa Diamond, BSc, JD/MSEL

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Guilherme Sant'Anna, MD

Disqualifiers: Preterm birth, Unstable condition, Skin abnormalities

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

Compensation: Varies

Number of Visits: 1

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new wireless skin sensor system for monitoring vital signs in newborns immediately after birth. Researchers aim to determine if these sensors perform as effectively as traditional wired systems in tracking heart rate and breathing. The focus is on healthy newborns who are at least 35 weeks gestational age and have no skin issues. The trial compares the performance of both systems in babies born vaginally and those delivered by C-section, with monitoring lasting two hours. As an unphased trial, this study provides an opportunity to contribute to innovative technology that could enhance newborn care.

Will I have to stop taking my current medications?

The trial is for newborns and does not mention any medication requirements for participants.

What prior data suggests that this wireless skin sensor monitoring system is safe for newborns?

A previous study used wireless skin sensors in neonatal intensive care units (NICUs) to monitor babies' vital signs, such as heart rate and breathing. The study found these sensors safe for newborns. Research shows they are non-invasive, meaning they don't break the skin, and they function without harming the babies. Designed for comfort, the sensors do not interfere with the baby's care or movement.

Testing has confirmed the sensors' safety and accuracy, ensuring reliable monitoring of vital signs like temperature and heart rate. Reports indicate they are well-tolerated, with no significant unwanted side effects noted in studies. This means they have been used without causing problems for the babies involved.

Overall, evidence suggests these wireless skin sensors are a safe option for monitoring vital signs in newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wireless skin sensors for neonatal care because they offer a new way to monitor vital signs in newborns without the use of wires, which can be cumbersome and restrictive. Unlike traditional wired monitors, these wireless sensors can provide continuous and comfortable monitoring, allowing for more mobility and ease for both the baby and caregivers. This innovation could potentially reduce the risk of skin irritation and infection associated with wired systems and improve the overall experience in neonatal care settings.

What evidence suggests that this wireless skin sensor system is effective for monitoring vital signs in newborns?

Research has shown that wireless skin sensors for newborns monitor vital signs as accurately as traditional wired systems. In this trial, participants will be assigned to different arms based on the type of birth. For vaginal births, the wireless monitoring system will be placed first, followed by the wired system. For C-section births, the order of system placement will be randomized. One study found these wireless sensors safe, accurate, and reliable for tracking heart rate and other vital signs. This new technology can prevent injuries from wires and create a more family-friendly environment. The sensors offer a promising alternative to traditional methods by providing accurate results without wires. ^{1 2 3 4 5}

Who Is on the Research Team?

Guilherme Sant'Anna, MD, PhD

Principal Investigator

The Research institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for healthy newborns born at or after 35 weeks of pregnancy. It aims to see if a new wireless sensor system can track their vital signs right after birth and during the first two hours under unsupervised parental care.

Inclusion Criteria

My newborn has normal skin.

My newborn was stable at birth.

My newborn is at least 35 weeks old in gestational age.

Exclusion Criteria

My baby was born at or before 35 weeks of pregnancy.

My newborn was not stable after birth.

My newborn has skin abnormalities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Monitoring

Newborns are monitored using both wireless and wired vital sign monitoring systems immediately after delivery for 2 hours

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial monitoring period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Wireless skin sensors vital sign monitoring system

Trial Overview The study compares an advanced wireless skin sensor system with the traditional wired system for monitoring vital signs in newborns. Researchers will check how feasible, safe, and accurate the wireless system is immediately after delivery.

How Is the Trial Designed?

Group I: Vaginal Birth Experimental Treatment 2 Interventions

Wireless monitoring system placed first for vaginal birth. 15-20 minutes later, the wired monitoring system is placed. Both systems stay in place for 2 hours.

Group II: C-Section Birth Experimental Treatment 2 Interventions

System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.

Who Is Running the Clinical Trial?

Guilherme Sant'Anna, MD

Lead Sponsor

Trials

3

Recruited

660+

University of Campinas, Brazil

Collaborator

Trials

196

Recruited

37,700+

Sanatorio de la Trinidad Palermo

Collaborator

Trials

1

Recruited

600+

Federal University of Uberlandia

Collaborator

Trials

63

Recruited

6,400+

Mbuya Nehanda Hospital Harare Zimbabwe

Collaborator

Trials

1

Recruited

600+

Hopsital Central de Maputo, Mozambique

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10312156/

The use of wireless sensors in the neonatal intensive care ... This study will evaluate feasibility, safety, and accuracy of a new wireless monitoring technology in neonates treated in the NICU.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589750021000017

Wireless skin sensors for physiological monitoring of ... Novel, wireless, and biointegrated sensors provide opportunities to enhance monitoring capabilities, reduce iatrogenic injuries, and promote family-centric care ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/17/NCT06693817/ICF_002.pdf

Study Title: Advanced Wireless Sensors for Neonatal Care ... The purpose of this study is to understand if the Anne Arc™ wireless, non-invasive skin sensor is an accurate, safe, and reliable method for ...

4. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2025.1555882/full

Wireless skin sensors for electrocardiogram and heart rate ... ECG and HR monitoring using a new wireless skin sensor was feasible, safe, and accurate when compared to the wired standard.

5. nature.com nature.com/articles/s41598-025-00539-9

Continuous non-contact vital sign monitoring of neonates ... We present a novel system to capture vital signs while offering clinical insights beyond current technologies using a single RGB-D camera.