Advanced Wireless Sensors for Neonatal Care in the Delivery Room
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system.
- Who it may be relevant to
- Registry conditions: Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia. Basic parameters: 35 Weeks — 42 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Canada, Italy, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Time between sensors placement and data display (seconds) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Newborns ≥35 weeks (gestational age)
- Newborns determined to be clinically stable at delivery
- Newborns with no skin abnormalities
Exclusion criteria
- Newborns ≤ 35 weeks (gestational age)
- Newborns determined to not be clinically stable at delivery
- Newborns with Skin abnormalities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 2 centers
- Montreal Children's Hospital — Montreal
- Royal Victoria Hospital — Montreal
Brazil · 1 center
- Hospital Universitário da Universidade Estadual de Londrina — Londrina
Italy · 1 center
- Nuovo Ospedale degli Infermi — Ponderano
Switzerland · 1 center
- Lucerne Cantonal Hospital — Lucerne
Identifiers
NCT: NCT06693817 · AWARD Study