Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 11
- 主要终点
- Feasibility of using a wireless monitoring system immediately after delivery for HR.
研究概览
简要总结
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:
- Assess feasibility
- Evaluate safety
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns ≥35 weeks (gestational age)
- •Newborns determined to be clinically stable at delivery
- •Newborns with no skin abnormalities
排除标准
- •Newborns ≤ 35 weeks (gestational age)
- •Newborns determined to not be clinically stable at delivery
- •Newborns with Skin abnormalities
研究组 & 干预措施
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.
干预措施: Wireless skin sensors vital sign monitoring system (Device)
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.
干预措施: Wireless skin sensors vital sign monitoring system (Device)
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.
干预措施: Wired vital sign monitoring system (Device)
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.
干预措施: Wired vital sign monitoring system (Device)
结局指标
主要结局
Feasibility of using a wireless monitoring system immediately after delivery for HR.
时间窗: 6 months
Percentage of time for which heart rate (HR) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for RR.
时间窗: 6 months
Percentage of time for which respiratory rate (RR) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for SpO2.
时间窗: 6 months
Percentage of time for which blood oxygen saturation (SpO2) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery for Tskin
时间窗: 6 months
Percentage of time for which skin temperature (Tskin) is displayed.
Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence
时间窗: 6 months
Occurrence of gaps in signal detection/recordings (% and length in seconds).
Feasibility of using a wireless monitoring system immediately after delivery - Gap causes
时间窗: 6 months
Causes of the gaps in signal detection/recordings.
Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction
时间窗: 6 months
Descriptive analysis of user surveys and their satisfaction with the wireless system.
Safety of using a wireless system immediately after delivery - skin score
时间窗: 6 months
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.
Safety of using a wireless system immediately after delivery - pain scale
时间窗: 6 months
Pain scale (Neonatal Infant Pain Scale) to assess any discomfort or pain during the removal of the sensors, with higher scores indicating greater pain.
Safety of using a wireless system immediately after delivery - clinical event discrepancies
时间窗: 6 months
Clinically significant events detected by the wired system (HR \< 100 bpm or SpO2 \< 80%) but missed by the wireless system.
Assess the accuracy of this wireless system - correlation coefficient.
时间窗: 6 months
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Correlation coefficient
Assess the accuracy of this wireless system - slope
时间窗: 6 months
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Slop
Assess the accuracy of this wireless system - variance accounted for
时间窗: 6 months
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Variance accounted for
Assess the accuracy of this wireless system - bias.
时间窗: 6 months
Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Bias
次要结局
- Time between sensors placement and data display (seconds)(6 months)
研究者
Guilherme Sant'Anna, MD
Senior Clinician Scientist, Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre