Neonatal EncephalopathyNBTNCT07857070
Newborn Brain Assessment - CergenX Wave
An observational study of Neonatal Encephalopathy and Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), run by CergenX Limited at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 weeks and older
- Conditions the study is for
- Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), Neonatal Encephalopathy, Unspecified
- What is being tested?
- CergenX Wave
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants at high-risk of Neonatal Encephalopathy
Who may be able to join
- Infants born at ≥36+0 weeks gestational age
- Informed consent obtained AND
- A pH of ≤7.0 or base deficit ≥16 (on cord or 1st infant blood gas at < 1 hour of life) OR
- 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
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- 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
Who cannot join
- Infants < 36 weeks gestation
- No parental/guardian consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Lina Chalak, 214-648-3060, Lina.Chalak@UTSouthwestern.edu
Ireland1 site
Cork University Maternity Hospital
Cork, Cork
Aisling Fanning, +353214920525, aisling.fanning1@hse.ie
About this study
Official title: Determining Grade of Neonatal Encephalopathy - Agreement Between the Modified Sarnat Examination and Automated AI Assessment of Newborn Brain Function Using Wave Software
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.
- Conditions
- Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), Neonatal Encephalopathy, Unspecified
- Being tested
- CergenX Wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CergenX WaveDevice
Also called eego amplifier
The amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Neonates at risk of Neonatal Encephalopathy Receives: Device: CergenX Wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the enrolment and up to 6 hours after birth
Secondary outcomes (4)
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.
Measured: 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.
Measured: From enrolment of the participant and up to 30 hours after birth
Association between CergenX Wave software and clinical variables including discharge diagnosis
Discharge diagnoses will be based on the clinical teams ultimate determination, and for analysis will be stratified as perinatal asphyxia without encephalopathy, mild neonatal encephalopathy, moderate encephalopathy, severe encephalopathy or alternate diagnosis. Descriptive statistics will be used to explore the frequency of the output of the Wave device with these diagnoses
Measured: From enrolment of the participant and up to 30 hours after birth
Assessment of healthcare professional (device users) satisfaction with usability of the device.
An adapted System Usability Scale (SUS) will be used, referred to as a User Experience Questionnaire that utilises a Likert scale.
Measured: From enrolment of the participant and up to 30 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CergenX Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INFANT centre, University College Cork, Republic of Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857070
- Sponsor's protocol ID
- 25116
- Other IDs
- DT 2023 0435
- Acronym
- NBT
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Grade of Neonatal Encephalopathy - Agreement Between the Modified Sarnat Examination and Automated AI Assessment of Newborn Brain Function Using Wave Software
- ClinicalTrials.gov ID
- NCT07857070
- Acronym / sponsor ID
- NBT / 25116
- Conditions
- Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), Neonatal Encephalopathy, Unspecified
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- CergenX LimitedIndustry (pharma, biotech, devices)
- Collaborators
- INFANT centre, University College Cork, Republic of Ireland
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Device: CergenX WaveNeonates at risk of Neonatal Encephalopathy |
Who may qualify
- Ages
- 36 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants at high-risk of Neonatal Encephalopathy
Key inclusion criteria (15 listed)
- Infants born at ≥36+0 weeks gestational age
- Informed consent obtained AND
- A pH of ≤7.0 or base deficit ≥16 (on cord or 1st infant blood gas at < 1 hour of life) OR
- 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:
Key exclusion criteria (2 listed)
- Infants < 36 weeks gestation
- No parental/guardian consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CergenX WaveAlso: eego amplifierThe amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer. | Device | Neonates |
Primary outcome
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
4 secondary outcomes
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.
Time frame: 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.
Time frame: From enrolment of the participant and up to 30 hours after birth
Association between CergenX Wave software and clinical variables including discharge diagnosis
Time frame: From enrolment of the participant and up to 30 hours after birth
Assessment of healthcare professional (device users) satisfaction with usability of the device.
Time frame: From enrolment of the participant and up to 30 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Neonatal Encephalopathy
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A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
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A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
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An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy and Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), run by CergenX Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Walsh, Neonatologist (+353214920525, brianhenry.walsh@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.