Newborn Brain Assessment - CergenX Wave

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

36 weeks - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

165 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 of 10-15.9 (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/tight nuchal cord
• Shoulder dystocia
• Uterine rupture
• Maternal haemorrhage/placental abruption
• Maternal trauma (e.g. vehicle accident)
• Mother received CPR

Exclusion Criteria:

1. Infants \< 36 weeks gestation
2. No parental/guardian consent

Study population

Infants at high-risk of Neonatal Encephalopathy

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

CergenX Limited

Study start

Oct 22, 2026 Actual

Primary completion

2027-10 Estimated

Study completion

2027-10 Estimated

First posted

Oct 5, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts