An interventional study of Wireless skin sensors vital sign monitoring system and Wired vital sign monitoring system in Sudden Unexplained Infant Death, Apnea of Newborn and Newborn Morbidity, sponsored by Guilherme Sant'Anna, MD. Recruiting at 5 sites in 4 countries. Open to participants aged 35 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Guilherme Sant'Anna, MD · Not applicable, Interventional, and Other
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:
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's planned enrollment of 600 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Guilherme Sant'Anna, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Device: Wireless skin sensors vital sign monitoring system · Device: Wired vital sign monitoring system
System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.
Device: Wireless skin sensors vital sign monitoring system · Device: Wired 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.
Also known as: Anne Arc (Sibel Health Inc), Radical-7 (Masimo)
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.
Also known as: Infinity M540 (Draeger)
Feasibility of using a wireless monitoring system immediately after delivery for HR.
Percentage of time for which heart rate (HR) is displayed.
Time frame: 6 months
Feasibility of using a wireless monitoring system immediately after delivery for RR.
Percentage of time for which respiratory rate (RR) is displayed.
Time frame: 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.
Time frame: 6 months
Feasibility of using a wireless monitoring system immediately after delivery for Tskin
Percentage of time for which skin temperature (Tskin) is displayed.
Time frame: 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).
Time frame: 6 months
Feasibility of using a wireless monitoring system immediately after delivery - Gap causes
Causes of the gaps in signal detection/recordings.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Time between sensors placement and data display (seconds)
To determine the time (seconds)between sensors placement and data display for each system (seconds)
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 27 months after the start.
Of 33 non-industry interventional studies with no phase under Asphyxia Neonatorum, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 27 months is above that.
Counting every sponsor, half of 33 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Guilherme Sant'Anna, MD