Recruiting

Observational Study

Sponsor:

Guilherme Sant'Anna, MD

Code:

NCT06693817

Conditions

Sudden Unexplained Infant Death

Apnea of Newborn

Newborn Morbidity

Newborn Asphyxia

Birth Outcome, Adverse

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Wireless skin sensors vital sign monitoring system

Wired vital sign monitoring system

Study Details

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.

Conditions

Sudden Unexplained Infant Death

Apnea of Newborn

Newborn Morbidity

Newborn Asphyxia

Birth Outcome, Adverse

Study ID

NCT06693817

Start date

Apr 8, 2025

Status verified date

May, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Feasibility of using a wireless monitoring system immediately after delivery for HR. [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery for RR. [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery for SpO2. [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery for Tskin [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery - Gap causes [ Time Frame: 6 months ]
  • Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction [ Time Frame: 6 months ]
  • Safety of using a wireless system immediately after delivery - skin score [ Time Frame: 6 months ]
  • Safety of using a wireless system immediately after delivery - pain scale [ Time Frame: 6 months ]
  • Safety of using a wireless system immediately after delivery - clinical event discrepancies [ Time Frame: 6 months ]
  • Assess the accuracy of this wireless system - correlation coefficient. [ Time Frame: 6 months ]
  • Assess the accuracy of this wireless system - slope [ Time Frame: 6 months ]
  • Assess the accuracy of this wireless system - variance accounted for [ Time Frame: 6 months ]
  • Assess the accuracy of this wireless system - bias. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Guilherme Sant´Anna, MD, PhD

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

Alyssa Maximov, BSc

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

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Guilherme Sant'Anna, MD

1-514-412-4400guilherme.santanna@mcgill.ca

Principal Investigator:

Guilherme Sant'Anna, MD

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Guilherme Sant'Anna, MD

Last update posted

May 8, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Guilherme Sant'Anna, MD on 2026-05-08.