Sudden Unexplained Infant DeathAWARDNCT06693817
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
A study testing Wireless skin sensors vital sign monitoring system and Wired vital sign monitoring system in people with Sudden Unexplained Infant Death and Apnea of Newborn, run by Guilherme Sant'Anna, MD at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity
- What is being tested?
- Wireless skin sensors vital sign monitoring system and Wired vital sign monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 8 Apr 2025to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns ≥35 weeks (gestational age)
- Newborns determined to be clinically stable at delivery
- Newborns with no skin abnormalities
Who cannot join
- Newborns ≤ 35 weeks (gestational age)
- Newborns determined to not be clinically stable at delivery
- Newborns with Skin abnormalities
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Canada2 sites, 2 recruiting
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Guilherme Sant'Anna, MD, 1-514-412-4400 ext. 23489, guilherme.santanna@mcgill.ca
Guilherme Sant'Anna, MD
- Recruiting
Royal Victoria Hospital
Montreal, Quebec
Guilherme Sant'Anna, MD, PhD
Brazil1 site, 1 recruiting
- Not yet recruiting
Hospital Universitário da Universidade Estadual de Londrina
Londrina, Paraná, 86038-350
Adriana Zani
Italy1 site, 1 recruiting
- Not yet recruiting
Nuovo Ospedale degli Infermi
Ponderano, BI, 13875
Paolo Manzoni, MD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Lucerne Cantonal Hospital
Lucerne, Canton of Lucerne
Urs Schumacher
About this study
Official title: Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
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:
- Assess feasibility
- Evaluate safety
- 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.
Read the detailed 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.
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia, Birth Outcome, Adverse, Birth Asphyxia
- Being tested
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Keywords
- Delivery Room, Newborn, Neonatal Resuscitation, Wireless Technology, Vital Sign Monitoring, Sudden Unexplained Post-Natal Collapse, SUPC, Obstetrical Center, Obstetrics, Neonate, Birth, Birthing Center, C-Section, Vaginal Delivery, Sensors, Heart Rate (HR), Respiratory Rate (RR), Blood Oxygen Saturation (SpO2), Skin Temperature (Tskin), Pulse Rate (PR)
- Medical subject headings
- Asphyxia Neonatorum, Pregnancy Complications, Infant Death, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless skin sensors vital sign monitoring systemDevice
Also called Anne Arc (Sibel Health Inc), Radical-7 (Masimo)
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 systemDevice
Also called Infinity M540 (Draeger)
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Birth | Other | 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. Receives: Device: Wireless skin sensors vital sign monitoring system; Device: Wired vital sign monitoring system |
| C-Section Birth | Other | System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours. Receives: Device: Wireless skin sensors vital sign monitoring system; Device: Wired vital sign monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using a wireless monitoring system immediately after delivery for HR.
Percentage of time for which heart rate (HR) is displayed.
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery for RR.
Percentage of time for which respiratory rate (RR) is displayed.
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery for SpO2.
Percentage of time for which blood oxygen saturation (SpO2) is displayed.
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery for Tskin
Percentage of time for which skin temperature (Tskin) is displayed.
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence
Occurrence of gaps in signal detection/recordings (% and length in seconds).
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery - Gap causes
Causes of the gaps in signal detection/recordings.
Measured: 6 months
Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction
Descriptive analysis of user surveys and their satisfaction with the wireless system.
Measured: 6 months
Safety of using a wireless system immediately after delivery - skin score
Skin score (Neonatal Skin Condition Score) to be determined by a blinded dermatologist using de-identified pictures of the skin after removal of the sensors of each system. A "perfect" score using the NSCS is 3; the worst score is 9.
Measured: 6 months
Safety of using a wireless system immediately after delivery - pain scale
Pain scale (Neonatal Infant Pain Scale) to assess any discomfort or pain during the removal of the sensors, with higher scores indicating greater pain.
Measured: 6 months
Safety of using a wireless system immediately after delivery - clinical event discrepancies
Clinically significant events detected by the wired system (HR < 100 bpm or SpO2 < 80%) but missed by the wireless system.
Measured: 6 months
Assess the accuracy of this wireless system - correlation coefficient.
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Correlation coefficient
Measured: 6 months
Assess the accuracy of this wireless system - slope
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Slop
Measured: 6 months
Assess the accuracy of this wireless system - variance accounted for
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Variance accounted for
Measured: 6 months
Assess the accuracy of this wireless system - bias.
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Bias
Measured: 6 months
Secondary outcomes (1)
Time between sensors placement and data display (seconds)
To determine the time (seconds)between sensors placement and data display for each system (seconds)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start8 Apr 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexplained Infant DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guilherme Sant'Anna, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitário da Universidade Estadual de Londrina, Nuovo Ospedale degli Infermi, Luzerner Kantonsspital
- Responsible party
- Sponsor-investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme Sant'Anna, MD, PhD, Principal investigator, The Research institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693817
- Sponsor's protocol ID
- AWARD Study
- Acronym
- AWARD
- Status last verified
- May 2026
- First submitted
- 30 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No