Wireless Sensors for Neonatal Care

(AWARD Trial)

Recruiting at 6 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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Wireless skin sensors vital sign monitoring system?

Research shows that wireless skin sensors for neonatal care provide accurate monitoring of vital signs like heart rate and temperature, similar to traditional wired systems, but with added benefits like reduced risk of skin injuries and improved parent-infant interaction. ^{1 2 3 4 5}

Is the wireless sensor system for neonatal care safe for use in humans?

Research indicates that wireless sensor systems for neonatal care are generally safe, with studies showing no serious adverse effects in monitored patients. These systems reduce risks associated with traditional wired sensors, such as skin injuries and complications in care. ^{1 2 3 4 6}

How does the wireless skin sensors vital sign monitoring system differ from other treatments for neonatal care?

The wireless skin sensors for neonatal care are unique because they are soft, ultrathin, and operate without wires or batteries, reducing the risk of skin damage and allowing for better parent-infant interaction. Unlike traditional systems, these sensors provide continuous, real-time monitoring of vital signs with additional features like movement tracking and acoustic monitoring, all while being gentle on the baby's skin. ^{1 2 3 4 7}

What is the purpose of this trial?

The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to: 1. Assess feasibility 2. Evaluate safety 3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.

Research Team

Guilherme Sant'Anna, MD, PhD

Principal Investigator

The Research institute of the McGill University Health Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Skin-interfaced biosensors for advanced wireless physiological monitoring in neonatal and pediatric intensive-care units. [2021]

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

Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Skin-Integrated Devices with Soft, Holey Architectures for Wireless Physiological Monitoring, With Applications in the Neonatal Intensive Care Unit. [2022]

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

The use of wireless sensors in the neonatal intensive care unit: a study protocol. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sensors in neonatal monitoring: current practice and future trends. [2004]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

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