Newborn Brain Assessment - CergenX Wave

Condition(s) studied

Investigational drug(s) / intervention(s)

CergenX Wave: The amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 — From the enrolment and up to 6 hours after birth

Trial sites (2)

Other trials for the same condition