In this study we want to assess how a newly developed software device called CergenX Wave compares to the modified Sarnat examination, performed by the neonatology team . The Wave software algorithm (which is a set of rules used by the computer) analyses EEG activity, using four electrodes placed on the neonate's scalp.
A portable EEG machine records the EEG activity and a tablet will send this information to the cloud where the device analyses the data, as shown in the figure below. The EEG activity the Wave device evaluates will not be available to either the research or clinical team during the investigation but once the recording is completed the device will display a code on screen for the research team to confirm completion.
The results will not be visible to either the researchers or the clinical team therefore will not in any way influence the care of the neonate. This is a regulated observational investigation to compare how the software performs against the current standard of care, a standardised neurological examination.
Infants born at ≥36+0 weeks gestational age
Informed consent obtained AND
A pH of ≤7.0 or base deficit ≥16 (on cord or 1st infant blood gas at < 1 hour of life) OR
An APGAR score ≤5 at 10 minutes OR
Infants < 36 weeks gestation
No parental/guardian consent
Infants at high-risk of Neonatal Encephalopathy
Case-only
Prospective
CergenX Wave
DeviceThe amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.
Percentage agreement between the CergenX Wave result and stage of NE assigned by modified Sarnat examination (i.e. normal/mild abnormality versus moderate/severe abnormality) between 1-6 hours of life
Change in agreement between the modified Sarnat examination and the software-based assessment from the initial assessment (1-6 hours of life) to 24 hours of life (± 6 hours) among infants with initial disagreement.
Level of agreement between modified Sarnat examination, Wave software, and aEEG/cEEG classification at the same time point in infants with available neurophysiologic monitoring.
Association between CergenX Wave software and clinical variables including discharge diagnosis
Discharge diagnoses will be based on the clinical teams ultimate determination, and for analysis will be stratified as perinatal asphyxia without encephalopathy, mild neonatal encephalopathy, moderate encephalopathy, severe encephalopathy or alternate diagnosis. Descriptive statistics will be used to explore the frequency of the output of the Wave device with these diagnoses
Assessment of healthcare professional (device users) satisfaction with usability of the device.
An adapted System Usability Scale (SUS) will be used, referred to as a User Experience Questionnaire that utilises a Likert scale.
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CergenX Limited
Lead sponsor
INFANT centre, University College Cork, Republic of Ireland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
