Newborn Brain Wave Checker: See if CergenX Wave matches the Sarnat exam
Official title: Determining Grade of Neonatal Encephalopathy - Agreement Between the Modified Sarnat Examination and Automated AI Assessment of Newborn Brain Function Using Wave Software
Run by CergenX Limited · NCT07857070 · Data updated 2026-11-12
This study tests whether the CergenX Wave software, which analyzes a newborn's EEG via a small four-electrode setup, can match the standard Sarnat examination in babies with suspected neonatal encephalopathy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 36 Weeks and up |
| Sex | All |
| Enrollment | 165 (estimated) |
| Sponsor | CergenX Limited Industry-sponsored |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Status | Recruiting |
| Started | October 22, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07857070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born at 36 weeks gestation or later who meet the specified cord blood gas or perinatal condition criteria and whose guardians provide informed consent.
✕Probably not a fit
Infants not meeting the eligibility criteria or whose EEG data do not demonstrate concordance with the Sarnat exam may not benefit from this tool.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares a new EEG-analysis software, CergenX Wave, against the modified Sarnat exam performed by the neonatology team. EEG data are collected with a portable device using four scalp electrodes and transmitted to the cloud for analysis. The investigators compare the Wave algorithm’s results with the traditional clinical assessment to see how well they align. Importantly, the EEG results are not disclosed to the care team during the study, so clinical management is not influenced by the device. This research is designed to evaluate the performance of the software in real-world neonatal encephalopathy cases.
Why it matters
Potential benefit: If successful, the CergenX Wave tool could provide an objective, rapid EEG-based aid to neonatal brain assessment in suspected encephalopathy.
How similar studies have gone: Previous work on EEG-based neonatal assessment shows potential but this exact algorithm and setup are novel in this observational context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Cork University Maternity Hospital
Cork, Cork, Ireland Recruiting -
University of Texas Southwestern Medical Center
Dallas, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Brian Walsh, Neonatologist
- Email: brianhenry.walsh@ucc.ie
- Phone: +353214920525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.