[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659039":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":11,"studyPopulation":28,"armGroups":29,"interventions":35,"overallOfficials":11,"centralContacts":43,"locations":49,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":11,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":11,"briefSummary":102,"conditions":103,"keywords":11,"overallStatus":107,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"CergenX Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage agreement between the CergenX Wave result and stage of NE assigned by modified Sarnat examination (i.e. normal\u002Fmild abnormality versus moderate\u002Fsevere abnormality) between 1-6 hours of life",null,"From the enrolment and up to 6 hours after birth",[14,17,19,22],{"measure":15,"description":11,"timeFrame":16},"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",{"measure":18,"description":11,"timeFrame":16},"Level of agreement between modified Sarnat examination, Wave software, and aEEG\u002FcEEG classification at the same time point in infants with available neurophysiologic monitoring.",{"measure":20,"description":21,"timeFrame":16},"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",{"measure":23,"description":24,"timeFrame":16},"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.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":26,"timePerspective":27,"maskingInfo":11},"CASE_ONLY","PROSPECTIVE","Infants at high-risk of Neonatal Encephalopathy",[30],{"label":31,"type":11,"description":32,"interventionNames":33},"Neonates","Neonates at risk of Neonatal Encephalopathy",[34],"Device: CergenX Wave",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","CergenX Wave","The amplifier is used to acquire and transmit the EEG to the CergenX Wave software that is installed in a COTS computer.",[31],[42],"eego amplifier",[44],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Brian Walsh, Neonatologist","CONTACT","+353214920525","brianhenry.walsh@ucc.ie",[50,68],{"facility":51,"status":11,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Texas Southwestern Medical Center","Dallas","Texas","75235","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-96.80667,32.78306,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":11,"email":67},"Lina Chalak","214-648-3060","Lina.Chalak@UTSouthwestern.edu",{"facility":69,"status":11,"city":70,"state":70,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Cork University Maternity Hospital","Cork","Ireland","IE",{"type":58,"coordinates":74},[75,76],-8.47061,51.89797,{"lat":76,"lon":75},[79],{"name":80,"role":46,"phone":47,"phoneExt":11,"email":81},"Aisling Fanning","aisling.fanning1@hse.ie",{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[85],{"name":86,"class":87},"INFANT centre, University College Cork, Republic of Ireland","UNKNOWN","100659039","newborn-brain-assessment---cergenx-wave-100659039",false,"NCT07857070","Newborn Brain Assessment - CergenX Wave","Determining Grade of Neonatal Encephalopathy - Agreement Between the Modified Sarnat Examination and Automated AI Assessment of Newborn Brain Function Using Wave Software","NBT","Inclusion Criteria:\n\n1. Infants born at ≥36+0 weeks gestational age\n2. Informed consent obtained AND\n3. A pH of ≤7.0 or base deficit ≥16 (on cord or 1st infant blood gas at \\\u003C 1 hour of life) OR\n4. a) A pH of 7.01-7.15 or base deficit ≥ 16 (on cord or 1st infant blood gas at \\\u003C 1 hour of life) WITH b) at least one of the following:\n\n   * An APGAR score ≤5 at 10 minutes OR\n   * Prolonged resuscitation (infant receiving IPPV at ≥10 minutes of life) OR\n   * An acute perinatal event:\n\n     * Abnormal CTG (variable\u002Flate foetal HR decelerations)\n     * Foetal bradycardia\n     * Prolapsed\u002Fruptured\u002Ftight nuchal cord\n     * Shoulder dystocia\n     * Uterine rupture\n     * Maternal haemorrhage\u002Fplacental abruption\n     * Maternal trauma (e.g. vehicle accident)\n     * Mother received CPR\n\nExclusion Criteria:\n\n1. Infants \\\u003C 36 weeks gestation\n2. No parental\u002Fguardian consent","ALL","36 Weeks",{"count":99,"type":100},165,"ESTIMATED","OBSERVATIONAL","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.\n\nA 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.\n\nThe 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.",[104,105,106],"Neonatal Encephalopathy","Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)","Neonatal Encephalopathy, Unspecified","NOT_YET_RECRUITING","2026-09-28",{"date":110,"type":111},"2026-10-05","ACTUAL",{"date":113,"type":100},"2026-09",{"date":115,"type":100},"2027-09",{"name":5,"class":6},2]