Newborn Brain Assessment - CergenX Wave

Part of paid clinical trials in Dallas, Texas.

Sponsor
CergenX Limited
Study ID
NCT07857070
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Neonatal Encephalopathy
  • Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
  • Neonatal Encephalopathy, Unspecified

Eligibility Criteria

Sex
ALL
Age
36 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 5, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
165 participants (estimated)

Arms

  • Arm: Neonates
    Neonates at risk of Neonatal Encephalopathy

Primary Outcome Measure

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 [ Time Frame: From the enrolment and up to 6 hours after birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75235
Lina Chalak
[email protected]
214-648-3060

Find similar trials in Dallas, TX

By research site
University of Texas Southwestern Medical Center· Dallas, TX

Related Studies