Advanced Wireless Sensors for Neonatal Care in the Delivery Room

NCT06693817 | Recruiting

• 1 other identifier: AWARD Study
• Study Type: interventional
• Target: 600
• Locations: 5 countries
• Sites: 7

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. 1.Assess feasibility
2. 2.Evaluate safety
3. 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.

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; Infant Death; Infant, Newborn, Diseases; Infant Apnea; Infant Conditions; Parents; Delivery Problem for Fetus; Delivery Complication

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); International; Low-Income; Middle-Income; High-Income; Golden Hour; Post-Birth

Outcome Measures

Primary Outcomes (14)

• Feasibility of using a wireless monitoring system immediately after delivery for HR.

  Percentage of time for which heart rate (HR) is displayed.

  6 months

• 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

• 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

• 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

Secondary Outcomes (1)

• Time between sensors placement and data display (seconds)

  6 months

Study Arms (2)

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.

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.

Device: Wireless skin sensors vital sign monitoring system; Device: Wired vital sign monitoring system

Interventions

Wireless skin sensors vital sign monitoring system DEVICE

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)

C-Section Birth; Vaginal Birth

Wired vital sign monitoring system DEVICE

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)

C-Section Birth; Vaginal Birth

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns ≥35 weeks (gestational age)
• Newborns determined to be clinically stable at delivery
• Newborns with no skin abnormalities

You may not qualify if:

• Newborns ≤ 35 weeks (gestational age)
• Newborns determined to not be clinically stable at delivery
• Newborns with Skin abnormalities

Sponsors & Collaborators

• Guilherme Sant'Anna, MD: lead
• Federal University of Uberlandia: collaborator
• University of Campinas, Brazil: collaborator
• Sanatorio de la Trinidad Palermo: collaborator
• Mbuya Nehanda Hospital Harare Zimbabwe: collaborator
• Hopsital Central de Maputo, Mozambique: collaborator

Study Sites (7)

Hospitals Sanatorio Trinidad Palermo

Buenos Aires, Argentina

NOT YET RECRUITING

Hospital de Clínicas de Uberlândia

Umuarama, Minas Gerais, 38405-320, Brazil

NOT YET RECRUITING

ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM

São Paulo, Brazil

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

RECRUITING

Maputo Central Hospital

Maputo, Mozambique

NOT YET RECRUITING

Mbuya Nehanda Hospital

Harare, Zimbabwe

NOT YET RECRUITING

MeSH Terms

Conditions

Asphyxia Neonatorum; Pregnancy Complications; Infant Death; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guilherme Sant'Anna, MD, PhD

  The Research institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme Sant´Anna, MD, PhD

CONTACT

514-934-1934; guilherme.santanna@mcgill.ca

Alyssa Maximov, BSc

CONTACT

514-934-1934; alyssa.maximov@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Clinician Scientist, Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 18, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); CA (2); AR (1); BR (2); ZI (1)