HeartLight: Heart Rate Monitoring for Newborn Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Heart Rate acquisition time in the first minute of life
研究概览
简要总结
This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy.
详细描述
Up to 10% of newborns require some form of resuscitation at birth. Heart rate (HR) is the most sensitive indicator of resuscitation efficacy. HR is most commonly estimated using a stethoscope. However, in simulation studies it has been shown that newborn healthcare providers estimate HR incorrectly in up to 1/3 of cases. Common techniques for monitoring heart rate such as electrocardiography (ECG) and pulse oximetry (PO) were not developed for resuscitation at birth.
ECG, an established and accurate method of monitoring HR, is rarely used in the delivery room for a number of reasons including difficulty ensuring adhesion to the skin (the baby is wet/covered in vernix) and skin damage in premature babies caused by stripping of the electrodes. Current ECG systems also require 3 electrodes to be positioned which can delay resuscitation further. The usual site for transmission PO is the foot or hand. However, in newborn babies, and particularly those requiring resuscitation when the HR is low, blood flow is reduced so physiological mechanisms preserve brain and heart blood flow at the expense of other less important organs and limbs. As a consequence of this and the choice of wavelengths, it can be more difficult to obtain a reliable HR from POs on the limbs, and they typically obtain an HR after 1-2 minutes.
In the delivery room, ECG and PO systems have a requirement for cables to connect to the main monitors. These can get in the way and it is now recommended for many babies to delay cutting the umbilical cord (to ensure more blood enters the baby from the placenta) which often requires the baby to be resuscitated very close to the mother and even between their legs.
The HeartLight system is a wireless optical sensor within a custom newborn hat to allow quick and accurate HR monitoring. It will be compared to ECG, PO and electronic stethoscope to determine the accuracy and reliability. The trial has 4 phases; Phase 1 evaluates the thermal properties of the hat, Phase 2 evaluates the accuracy and reliability of the HeartLight sensor on babies within the Neonatal Intensive Care Unit environment, Phase 3 evaluates the HeartLight sensor in newborn babies born by cesarean section and Phase 4 evaluates the performance of the HeartLight sensor in babies of all gestations requiring resuscitation and stabilisation at birth.
The investigators anticipate the HeartLight sensor and hat will allow swift and effective deployment, reduce delays in resuscitation (due to using a stethoscope) and improve HR accuracy (as a result of avoiding errors in the usual manual mental calculations made in the stressful environment of the delivery room) when it is needed most. However, an additional benefit is that it will not require significant modification to the existing care pathway or resuscitation protocols, and therefore a potential barrier to clinical uptake is removed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent from the mother
- •Realistic prospect of survival as determined by the attending clinical team
- •Infants on NICU
- •Infants on NICU requiring heart rate monitoring
- •Newborn infants following non-emergency elective cesarean section
- •Newborn infants who attending clinical team anticipate will require assessment of heart rate at time of birth
- •Mothers of babies recruited into HeartLight study
- •Healthcare professionals exposed to the new device
排除标准
- •Infants undergoing palliative care
- •Infants too sick to tolerate additional procedures
- •Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies).
- •Any infant in whom resuscitation is likely to be required.
- •If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
- •Infants <23 weeks
- •Infants that are not for active resuscitation as decided by the clinical team
- •If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
- •Unable to obtain written informed consent
结局指标
主要结局
Heart Rate acquisition time in the first minute of life
时间窗: 1 hour
Time to acquire heart rate from new optical hat sensor from birth should be within 1 minute of birth.
次要结局
- Reliability of heart rate generated by HeartLight device(1 hour)
- Accuracy of heart rate generated by HeartLight device(1 hour)
- Feedback on acceptability of hat and device(1 hour)
- Thermal imaging to determine heat loss whilst wearing hat(1 hour)
- Thermal imaging to determine heat loss during stabilisation and/or resuscitation(1 hour)
