Clinical trial NCT02701920: HeartLight: Heart Rate Monitoring for Newborn Resuscitation
Official title: HeartLight: Heart Rate Monitoring for Newborn Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn, Diseases
Fetus or Neonate Affected by Cesarean Section
Infant, Premature, Diseases
Keywords: Premature Birth
Infant
Heart rate
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Heartlight Systems Limited
First posted: 2016-03-08
Enrollment: 184
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate acquisition time in the first minute of life
timeFrame: 1 hour
Secondary outcomes:
measure: Reliability of heart rate generated by HeartLight device
timeFrame: 1 hour
measure: Accuracy of heart rate generated by HeartLight device
timeFrame: 1 hour
measure: Feedback on acceptability of hat and device
timeFrame: 1 hour
measure: Thermal imaging to determine heat loss whilst wearing hat
timeFrame: 1 hour
measure: Thermal imaging to determine heat loss during stabilisation and/or resuscitation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham NHS Trust
Study officials:
affiliation: University of Nottingham
name: Don Sharkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: