Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Last updated: April 14, 2025
Sponsor: Guilherme Sant'Anna, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Wireless skin sensors vital sign monitoring system

Wired vital sign monitoring system

Clinical Study ID

NCT06693817
AWARD Study
  • Ages 35-42
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Newborns ≥35 weeks (gestational age)

  2. Newborns determined to be clinically stable at delivery

  3. Newborns with no skin abnormalities

Exclusion

Exclusion criteria:

  1. Newborns ≤ 35 weeks (gestational age)

  2. Newborns determined to not be clinically stable at delivery

  3. Newborns with Skin abnormalities

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Wireless skin sensors vital sign monitoring system
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
June 30, 2027

Study Description

When the transition from intrauterine to extrauterine life necessitates Neonatal Resuscitation, specialized monitoring of vital signs is required. Sudden Unexpected Postnatal Collapse (SUPC) is an apnea or cardiorespiratory failure occurring in otherwise healthy near-term or term neonates, usually in the first 48 hours of age, during the initial Kangaroo Mother Care (KMC) in the obstetrical center. SUPC carries a high morbidity and mortality rate. Approximately 10 million babies do not breathe immediately after birth, and 60% require basic resuscitation interventions. Sudden Unexpected Postnatal Collapse has been estimated to occur in 2.6-133 cases per 100.000 newborns and over 50% of the cases occur following accidental suffocation, which frequently goes unrecognised by parents in the obstetrical center during unsupervised KMC.

Current guidelines recommend monitoring of heart rate (HR), oxygen saturation (SpO2), and skin temperature (Tskin) during neonatal resuscitation. This is usually achieved by using wired electrodes and sensors that require expensive and large base units attached to a power supply. SUPC is a rare but largely preventable cause of neonatal mortality that deserves particular attention. Better resuscitation and prevention of SUPC might be achieved by continuous non-intrusive monitoring of vital signs immediately after delivery and while in the obstetrical center.

This research will address a very important gap in care; the need for safe and accurate advanced, non-invasive, and non-intrusive wireless technologies for monitoring of vital signs immediately after birth and during the immediate postnatal care, potentially preventing cases of SUPC while in the obstetrical center.

Reliable and low-cost wireless monitoring that could be used immediately after delivery would promote widespread adoption of neonatal resuscitation recommendations in low and middle income countries, improve detection of vital signs quickly after delivery and during early unsupervised KMC, and optimize neonatal care in the obstetrical centers or during hospital stay, to prevent cases of SUPC and its associated high mortality.

Connect with a study center

  • Hospitals Sanatorio Trinidad Palermo

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital de Clínicas de Uberlândia

    Umuarama, Minas Gerais 38405-320
    Brazil

    Site Not Available

  • ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM

    São Paulo,
    Brazil

    Site Not Available

  • Royal Victoria Hospital

    Montreal, Quebec
    Canada

    Active - Recruiting

  • Montreal Children's Hospital

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Maputo Central Hospital

    Maputo,
    Mozambique

    Site Not Available

  • Mbuya Nehanda Hospital

    Harare,
    Zimbabwe

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.