Advanced Wireless Sensors for Neonatal Care in the Delivery Room
NCT ID: NCT06693817
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-04-08
2027-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Vaginal Birth
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.
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.
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.
C-Section Birth
System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newborns determined to be clinically stable at delivery
3. Newborns with no skin abnormalities
Exclusion Criteria
2. Newborns determined to not be clinically stable at delivery
3. Newborns with Skin abnormalities
35 Weeks
42 Weeks
ALL
Yes
Sponsors
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Federal University of Uberlandia
OTHER
University of Campinas, Brazil
OTHER
Sanatorio de la Trinidad Palermo
UNKNOWN
Mbuya Nehanda Hospital Harare Zimbabwe
UNKNOWN
Hopsital Central de Maputo, Mozambique
UNKNOWN
Guilherme Sant'Anna, MD
OTHER
Responsible Party
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Guilherme Sant'Anna, MD
Senior Clinician Scientist, Professor
Principal Investigators
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Guilherme Sant'Anna, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Research institute of the McGill University Health Centre
Locations
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Hospitals Sanatorio Trinidad Palermo
Buenos Aires, , Argentina
Hospital de Clínicas de Uberlândia
Umuarama, Minas Gerais, Brazil
ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM
São Paulo, , Brazil
Montreal Children's Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Maputo Central Hospital
Maputo, , Mozambique
Mbuya Nehanda Hospital
Harare, , Zimbabwe
Countries
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Central Contacts
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Facility Contacts
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Guilherme Sant'Anna, MD, PhD
Role: primary
Other Identifiers
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AWARD Study
Identifier Type: -
Identifier Source: org_study_id
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