Advanced Wireless Sensors for Neonatal Care in the Delivery Room (AWARD)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Infant, Newborn, Diseases; Sudden Unexplained Infant Death; Infant Death; Pregnancy Related; Infant Conditions; Infant ALL; Parents; Newborn Morbidity; Newborn; Vitality; Birth Asphyxia; Delivery Complication; ECG Electrode Site Reaction; Infant Apnea; Newborn Asphyxia; Delivery Problem for Fetus; Apnea of Newborn; Birth Outcome, Adverse
• Intervention / Treatment: Device: Wired vital sign monitoring system; Device: Wireless skin sensors vital sign monitoring system

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 Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guilherme Sant´Anna, MD, PhD; Phone Number: 27049 514-934-1934; Email: guilherme.santanna@mcgill.ca
• Study Contact Backup: Name: Alyssa Maximov, BSc; Phone Number: 78229 514-934-1934; Email: alyssa.maximov@muhc.mcgill.ca

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86038-350
      • Not yet recruiting
      • Hospital Universitário da Universidade Estadual de Londrina
      • Contact: Adriana Zani
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Montreal Children's Hospital
      • Principal Investigator: Guilherme Sant'Anna, MD
      • Contact: Guilherme Sant'Anna, MD; Phone Number: 23489 1-514-412-4400; Email: guilherme.santanna@mcgill.ca
      • Principal Investigator: Wissam Shalish, MD
    • Montreal, Quebec, Canada
      • Recruiting
      • Royal Victoria Hospital
      • Contact: Guilherme Sant'Anna, MD, PhD
• Italy
  • BI
    • Ponderano, BI, Italy, 13875
      • Not yet recruiting
      • Nuovo Ospedale Degli Infermi
      • Contact: Paolo Manzoni, MD
• Switzerland
  • Canton of Lucerne
    • Lucerne, Canton of Lucerne, Switzerland
      • Not yet recruiting
      • Lucerne Cantonal Hospital
      • Contact: Urs Schumacher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Newborns ≥35 weeks (gestational age)
2. Newborns determined to be clinically stable at delivery
3. Newborns with no skin abnormalities

Exclusion criteria:

1. Newborns ≤ 35 weeks (gestational age)
2. Newborns determined to not be clinically stable at delivery
3. Newborns with Skin abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.; Other Names: Infinity M540 (Draeger); 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.; Other Names: Anne Arc (Sibel Health Inc); Radical-7 (Masimo)
Other: 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.	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.; Other Names: Infinity M540 (Draeger); 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.; Other Names: Anne Arc (Sibel Health Inc); Radical-7 (Masimo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of using a wireless monitoring system immediately after delivery for RR.	Percentage of time for which respiratory rate (RR) is displayed.	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.	6 months
Feasibility of using a wireless monitoring system immediately after delivery for Tskin	Percentage of time for which skin temperature (Tskin) is displayed.	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).	6 months
Feasibility of using a wireless monitoring system immediately after delivery - Gap causes	Causes of the gaps in signal detection/recordings.	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.	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.	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.	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	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	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	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	6 months
Feasibility of using a wireless monitoring system immediately after delivery for HR.	Percentage of time for which heart rate (HR) is displayed.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time between sensors placement and data display (seconds)	To determine the time (seconds)between sensors placement and data display for each system (seconds)	6 months

Collaborators and Investigators

• Sponsor: Guilherme Sant'Anna, MD
• Collaborators: Luzerner Kantonsspital; Hospital Universitário da Universidade Estadual de Londrina; Nuovo Ospedale degli Infermi
• Investigators: Principal Investigator: Guilherme Sant'Anna, MD, PhD, The Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obstetrics; Newborn; International; Neonate; Neonatal Resuscitation; Vaginal Delivery; Sensors; Heart Rate (HR); Birth; Delivery Room; Wireless Technology; C-Section; Low-Income; Vital Sign Monitoring; Sudden Unexplained Post-Natal Collapse; SUPC; Obstetrical Center; Birthing Center; Respiratory Rate (RR); Blood Oxygen Saturation (SpO2); Skin Temperature (Tskin); Pulse Rate (PR); Middle-Income; High-Income; Golden Hour; Post-Birth
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Death; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Asphyxia Neonatorum; Infant, Newborn, Diseases; Infant Death
• Other Study ID Numbers: AWARD Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes