CergenX Limited
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.
Inclusion Criteria: 1. Infants born at ≥36+0 weeks gestational age 2. Informed consent obtained AND 3. A pH of ≤7.0 or base deficit ≥16 (on cord or 1st infant blood gas at \< 1 hour of life) OR 4. a) A pH of 7.01-7.15 or base deficit ≥ 16 (on cord or 1st infant blood gas at \< 1 hour of life) WITH b) at least one of the following: * An APGAR score ≤5 at 10 minutes OR * Prolonged resuscitation (infant receiving IPPV at ≥10 minutes of life) OR * An acute perinatal event: * Abnormal CTG (variable/late foetal HR decelerations) * Foetal bradycardia * Prolapsed/ruptured/ti…
The amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.