[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CergenX Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},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.",[25,26,27],"Neonatal Encephalopathy","Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)","Neonatal Encephalopathy, Unspecified","NOT_YET_RECRUITING","2026-09-28",{"date":31,"type":32},"2026-10-05","ACTUAL",{"date":34,"type":21},"2026-09",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"CergenX Limited","INDUSTRY",2,""]