[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intraventricular-haemorrhage-grade-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intraventricular-haemorrhage-grade-iv":25},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100493665","prediction-of-intraventricular-hemorrhage-using-echocardiography-and-near-infrared-spectroscopy-100493665",false,"NCT05708105","Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy","PIONIRS","Inclusion Criteria:\n\n* Preterm infants born \\\u003C=27+6 weeks gestational age\n\nExclusion Criteria:\n\n* Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures\n* Palliative care plan prior to or immediately following delivery","ALL",{"count":18,"type":19},380,"ESTIMATED","OBSERVATIONAL","Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, \\\u003C=27+6 weeks) and is associated with long-term neuro-disabilities. In Canada, msIVH affects \\~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).",[23,24,25],"Intraventricular Hemorrhage of Newborn Grade 2","Intraventricular Hemorrhage of Newborn Grade 3","Intraventricular Haemorrhage Grade IV",[27,28,29,30],"Near-infrared spectroscopy","Echocardiography","Head ultrasound","Preterm neonates","RECRUITING","2025-03-19",{"date":34,"type":35},"2025-03-24","ACTUAL",{"date":37,"type":35},"2024-04-22",{"date":39,"type":19},"2027-11-01",{"name":41,"class":42},"Mount Sinai Hospital, Canada","OTHER",4]