Advanced Wireless Sensors for Neonatal Care in the Delivery Room

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.

Conditions

• Sudden Unexplained Infant Death
• Apnea of Newborn
• Newborn Morbidity
• Newborn Asphyxia
• Birth Outcome, Adverse
• Birth Asphyxia
• Pregnancy Related
• Newborn; Vitality
• ECG Electrode Site Reaction
• Infant ALL
• Infant Death
• Infant, Newborn, Diseases
• Infant Apnea
• Infant Conditions
• Parents
• Delivery Problem for Fetus
• Delivery Complication

Interventions

DEVICE

Wireless skin sensors vital sign monitoring system

The wireless monitoring system will be applied to the newborn and consist of a chest sensor (Anne Arc by Sibel Inc.) and a RAD-7 (Masimo)pulse oximeter limb sensor.

DEVICE

Wired vital sign monitoring system

A standard ECG and SpO2 monitoring device will be applied suing the Infinity M540 monitor (Draeger, Germany). The chest sensor will be placed as per standard of care on the newborn's chest and abdomen, and the SpO2 sensor on their hands or feet.

Sponsors & Collaborators

• Hospital Universitário da Universidade Estadual de Londrina

  collaborator UNKNOWN

• Nuovo Ospedale degli Infermi

  collaborator UNKNOWN

• Luzerner Kantonsspital

  collaborator OTHER

• Guilherme Sant'Anna, MD

  lead OTHER

Principal Investigators

• Guilherme Sant'Anna, MD, PhD · The Research institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

35 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-08

Primary Completion

2027-07-30

Completion

2027-12-30

Countries

• Brazil
• Canada
• Italy
• Switzerland

Study Locations