Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Not Applicable

Recruiting

• 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

• Registration Number: NCT06693817
• Lead Sponsor: Guilherme Sant'Anna, MD

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-18
• Status Verified: 2025-04
• Study Start: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-07-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Feasibility of using a wireless monitoring system immediately after delivery for HR.	6 months	Percentage of time for which heart rate (HR) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for RR.	6 months	Percentage of time for which respiratory rate (RR) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for SpO2.	6 months	Percentage of time for which blood oxygen saturation (SpO2) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for Tskin	6 months	Percentage of time for which skin temperature (Tskin) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence	6 months	Occurrence of gaps in signal detection/recordings (% and length in seconds).
Feasibility of using a wireless monitoring system immediately after delivery - Gap causes	6 months	Causes of the gaps in signal detection/recordings.
Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction	6 months	Descriptive analysis of user surveys and their satisfaction with the wireless system.
Safety of using a wireless system immediately after delivery - skin score	6 months	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.
Safety of using a wireless system immediately after delivery - pain scale	6 months	Pain scale (Neonatal Infant Pain Scale) to assess any discomfort or pain during the removal of the sensors, with higher scores indicating greater pain.
Safety of using a wireless system immediately after delivery - clinical event discrepancies	6 months	Clinically significant events detected by the wired system (HR \< 100 bpm or SpO2 \< 80%) but missed by the wireless system.
Assess the accuracy of this wireless system - correlation coefficient.	6 months	Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Correlation coefficient
Assess the accuracy of this wireless system - slope	6 months	Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Slop
Assess the accuracy of this wireless system - variance accounted for	6 months	Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Variance accounted for
Assess the accuracy of this wireless system - bias.	6 months	Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Bias

Secondary Outcome Measures

Name	Time	Method
Time between sensors placement and data display (seconds)	6 months	To determine the time (seconds)between sensors placement and data display for each system (seconds)

Trial Locations

Locations (7)

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

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Montreal Children's Hospital; 🇨🇦 Montréal, Quebec, Canada

Maputo Central Hospital; 🇲🇿 Maputo, Mozambique

Mbuya Nehanda Hospital; 🇿🇼 Harare, Zimbabwe