Advanced Wireless Sensors for Neonatal Care in the Delivery Room

NARecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

April 8, 2025

Primary Completion Date

July 30, 2026

Study Completion Date

June 30, 2027

Conditions
Sudden Unexplained Infant DeathApnea of NewbornNewborn MorbidityNewborn AsphyxiaBirth Outcome, AdverseBirth AsphyxiaPregnancy RelatedNewborn; VitalityECG Electrode Site ReactionInfant ALLInfant DeathInfant, Newborn, DiseasesInfant ApneaInfant ConditionsParentsDelivery Problem for FetusDelivery 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.

Trial Locations (7)

Unknown

NOT_YET_RECRUITING

Hospitals Sanatorio Trinidad Palermo, Buenos Aires

NOT_YET_RECRUITING

ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM, São Paulo

RECRUITING

Royal Victoria Hospital, Montreal

NOT_YET_RECRUITING

Maputo Central Hospital, Maputo

NOT_YET_RECRUITING

Mbuya Nehanda Hospital, Harare

38405-320

NOT_YET_RECRUITING

Hospital de Clínicas de Uberlândia, Umuarama

H4A 3J1

RECRUITING

Montreal Children's Hospital, Montreal

All Listed Sponsors
collaborator

Federal University of Uberlandia

OTHER

collaborator

University of Campinas, Brazil

OTHER

collaborator

Sanatorio de la Trinidad Palermo

UNKNOWN

collaborator

Mbuya Nehanda Hospital Harare Zimbabwe

UNKNOWN

collaborator

Hopsital Central de Maputo, Mozambique

UNKNOWN

lead

Guilherme Sant'Anna, MD

OTHER