HeartLight: Heart Rate Monitoring for Newborn Resuscitation
NCT ID: NCT02701920
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
184 participants
OBSERVATIONAL
2016-03-31
2018-05-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NICU infants and hat
Newborn infants of any gestation on the neonatal intensive care unit (NICU).
HeartLight hat
HeartLight hat will be worn for up to 1 hour.
The HeartLight hat with in-built sensor
The HeartLight hat with in-built sensor will be worn.
NICU infants and sensor
Newborn infants of any gestation requiring heart rate monitoring on the neonatal intensive care unit.
The HeartLight hat with in-built sensor
The HeartLight hat with in-built sensor will be worn.
HeartLight
Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
HeartLight device
HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
Newborns and surgical delivery
Well term newborn infants following birth by cesarean section.
The HeartLight hat with in-built sensor
The HeartLight hat with in-built sensor will be worn.
HeartLight
Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
HeartLight device
HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
Newborns needing stabilisation
Newborn infants requiring resuscitation or stabilisation following birth.
HeartLight
Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
HeartLight device
HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
Parental feedback
Parental feedback of babies recruited into HeartLight will be sought.
parental feedback
Questionnaire
Healthcare provider feedback
Healthcare professionals caring for babies recruited into HeartLight will have their feedback on the device sought.
healthcare provider feedback
Questionnaire
Interventions
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HeartLight hat
HeartLight hat will be worn for up to 1 hour.
The HeartLight hat with in-built sensor
The HeartLight hat with in-built sensor will be worn.
HeartLight
Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
HeartLight device
HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
parental feedback
Questionnaire
healthcare provider feedback
Questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Months
ALL
No
Sponsors
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Heartlight Systems Limited
INDUSTRY
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Don Sharkey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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University of Nottingham NHS Trust
Nottingham, , United Kingdom
Countries
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Other Identifiers
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15099
Identifier Type: -
Identifier Source: org_study_id
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