HeartLight: Heart Rate Monitoring for Newborn Resuscitation
HeartLight: Heart Rate Monitoring for Newborn Resuscitation
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.
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.
Inclusion Criteria:

 -  Written consent from the mother

 -  Realistic prospect of survival as determined by the attending clinical team

 Phase 1:

 - Infants on NICU

 Phase 2:

 - Infants on NICU requiring heart rate monitoring

 Phase 3:

 - Newborn infants following non-emergency elective cesarean section

 Phase 4:

 - Newborn infants who attending clinical team anticipate will require assessment of heart
 rate at time of birth

 Feedback:

 -  Mothers of babies recruited into HeartLight study

 -  Healthcare professionals exposed to the new device

 Exclusion Criteria:

 Phase 1+2:

 -  Infants undergoing palliative care

 -  Infants too sick to tolerate additional procedures

 Phase 3:

 -  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)

 Phase 4:

 -  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)

 Feedback:

 Unable to obtain written informed consent