An observational study in Infant, Newborn, Diseases, Fetus or Neonate Affected by Cesarean Section and Infant, Premature, Diseases, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged Up to 4 Months. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by University of Nottingham · Observational
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.
134 studies on the registry are indexed under Infant, Newborn, Diseases; 30 are open to participants now.
This study's enrollment of 184 is above the median of 114 across 50 observational studies indexed under Infant, Newborn, Diseases.
Browse Infant, Newborn, Diseases studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
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Infants
Phase 1:
Phase 2:
Phase 3:
Phase 4:
Feedback:
Exclusion Criteria:
Phase 1+2:
Phase 3:
Phase 4:
Feedback:
Unable to obtain written informed consent
Newborn infants of any gestation on the neonatal intensive care unit (NICU).
Device: HeartLight hat · Device: The HeartLight hat with in-built sensor
Newborn infants of any gestation requiring heart rate monitoring on the neonatal intensive care unit.
Device: The HeartLight hat with in-built sensor · Device: HeartLight · Device: HeartLight device
Well term newborn infants following birth by cesarean section.
Device: The HeartLight hat with in-built sensor · Device: HeartLight · Device: HeartLight device
Newborn infants requiring resuscitation or stabilisation following birth.
Device: HeartLight · Device: HeartLight device
Parental feedback of babies recruited into HeartLight will be sought.
Other: parental feedback
Healthcare professionals caring for babies recruited into HeartLight will have their feedback on the device sought.
Other: healthcare provider feedback
HeartLight hat will be worn for up to 1 hour.
The HeartLight hat with in-built sensor will be worn.
Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
Questionnaire
Questionnaire
Heart Rate acquisition time in the first minute of life
Time to acquire heart rate from new optical hat sensor from birth should be within 1 minute of birth.
Time frame: 1 hour
Reliability of heart rate generated by HeartLight device
Assess the reliability of the new heart rate device
Time frame: 1 hour
Accuracy of heart rate generated by HeartLight device
Assess the accuracy of the new heart rate device
Time frame: 1 hour
Feedback on acceptability of hat and device
Feedback will be recorded via a questionnaire from both healthcare professionals and mothers.
Time frame: 1 hour
Thermal imaging to determine heat loss whilst wearing hat
Participants will be thermal imaged whilst wearing the hat to determine heat loss.
Time frame: 1 hour
Thermal imaging to determine heat loss during stabilisation and/or resuscitation
Participants will be thermal imaged during stabilisation and/or resuscitation whilst wearing the hat to determine heat loss.
Time frame: 1 hour
Plan to share: Yes
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University of Nottingham