NBT
Determining Grade of Neonatal Encephalopathy - Agreement Between the Modified Sarnat Examination and Automated AI Assessment of Newborn Brain Function Using Wave Software
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Enterprise, Tourism and Employment. Enterprise Ireland
observational
165
2 countries
2
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 10, 2026
Actual (reported)October 5, 2026
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
From enrolment of the participant and up to 30 hours after birth
Level of agreement between modified Sarnat examination, Wave software, and aEEG/cEEG classification at the same time point in infants with available neurophysiologic monitoring.
From enrolment of the participant and up to 30 hours after birth
Association between CergenX Wave software and clinical variables including discharge diagnosis
From enrolment of the participant and up to 30 hours after birth
Assessment of healthcare professional (device users) satisfaction with usability of the device.
From enrolment of the participant and up to 30 hours after birth
Neonates at risk of Neonatal Encephalopathy
The amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Infants at high-risk of Neonatal Encephalopathy
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Cork University Maternity Hospital
Cork, Cork, Ireland
First Submitted
September 10, 2026
First Posted
October 5, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2027
EstimatedEnteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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