Clinical trial NCT06693817: Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Official title: Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Federal University of Uberlandia
name: University of Campinas, Brazil
name: Sanatorio de la Trinidad Palermo
name: Mbuya Nehanda Hospital Harare Zimbabwe
name: Hopsital Central de Maputo, Mozambique
First posted: 2024-11-18
Enrollment: 600
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of using a wireless monitoring system immediately after delivery for HR.
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery for RR.
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery for SpO2.
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery for Tskin
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery - Gap causes
timeFrame: 6 months
measure: Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction
timeFrame: 6 months
measure: Safety of using a wireless system immediately after delivery - skin score
timeFrame: 6 months
measure: Safety of using a wireless system immediately after delivery - pain scale
timeFrame: 6 months
measure: Safety of using a wireless system immediately after delivery - clinical event discrepancies
timeFrame: 6 months
measure: Assess the accuracy of this wireless system - correlation coefficient.
timeFrame: 6 months
measure: Assess the accuracy of this wireless system - slope
timeFrame: 6 months
measure: Assess the accuracy of this wireless system - variance accounted for
timeFrame: 6 months
measure: Assess the accuracy of this wireless system - bias.
timeFrame: 6 months
Secondary outcomes:
measure: Time between sensors placement and data display (seconds)
timeFrame: 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospitals Sanatorio Trinidad Palermo
city: Umuarama
country: Brazil
facility: Hospital de Clínicas de Uberlândia
state: Minas Gerais
city: São Paulo
country: Brazil
facility: ii. Hospital da Mulher Jose Aristodemo Pinotti State University of Campinas -CAISM
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Maputo
country: Mozambique
facility: Maputo Central Hospital
city: Harare
country: Zimbabwe
facility: Mbuya Nehanda Hospital
Study officials:
affiliation: The Research institute of the McGill University Health Centre
name: Guilherme Sant'Anna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: