Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Официальное название

Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Feasibility of using a wireless monitoring system immediately after delivery for HR. [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery for RR. [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery for SpO2. [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery for Tskin [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery - Gap causes [Срок оценки: 6 months]
• Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction [Срок оценки: 6 months]
• Safety of using a wireless system immediately after delivery - skin score [Срок оценки: 6 months]
• Safety of using a wireless system immediately after delivery - pain scale [Срок оценки: 6 months]
• Safety of using a wireless system immediately after delivery - clinical event discrepancies [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Time between sensors placement and data display (seconds) [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 2 центра

• Montreal Children's Hospital — Montreal
• Royal Victoria Hospital — Montreal

Бразилия · 1 центр

• Hospital Universitário da Universidade Estadual de Londrina — Londrina

Италия · 1 центр

• Nuovo Ospedale degli Infermi — Ponderano

Швейцария · 1 центр

• Lucerne Cantonal Hospital — Lucerne

Идентификаторы

NCT: NCT06693817 · AWARD Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗