[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573281":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":76,"collaborators":79,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":10,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Parma","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Mild Birth Asphyxia",null,"Term newborns (37-41 weeks of gestational age) with signs of moderate asphyxia at birth (cord pH \\\u003C 7.10 and\u002For BE \\> -12), with mild asphyxia at birth.",[13,14,15,16,17],"Diagnostic Test: Olfactory Testing","Diagnostic Test: Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2)","Diagnostic Test: Video-EEG","Diagnostic Test: fMRI","Diagnostic Test: Neurodevelopment assessment",{"label":19,"type":10,"description":20,"interventionNames":21},"Moderate - Severe Birth Asphyxia","Term newborns (37-41 weeks of gestational age) with signs of moderate asphyxia at birth (cord pH \\\u003C 7.10 and\u002For BE \\> -12) with moderate asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy, who don't need hypothermia treatment and with severe asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy who don't need hypothermia treatment.",[13,14,15,16,17],[23,28,32,36,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Olfactory Testing","Olfactory Test: Odor stimuli will be administered using a custom-designed olfactometer, developed by engineers specifically for this study. The olfactometer will release different odorants (maternal breast milk, vanilla essential oil, rose essential oil, and water as a control) in a controlled way. Each odor will be presented between 6 and 72 hours of life for 10 seconds (On), followed by a 50-second pause (Off) for a total of 15 cycles (On-Off). A new odor will be presented 5 minutes after the previous one. The first olfactory test will be conducted during the Video-EEG recording, and the second one will take place during the fMRI acquisition.",[9,19],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2)","Simultaneously with the presentation of odors, heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and peripheral oxygen saturation (SpO2) will be monitored and recorded. The onset of the odor will be recorded using a manual timer.",[9,19],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Video-EEG","The infant's Video-EEG, as per guidelines following perinatal asphyxia, will be recorded for approximately 2 hours, including the period preceding odor administration (baseline).",[9,19],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"fMRI","Newborns will undergo an fMRI, as part of routine clinical practice, to identify any brain injury, its extent, and the structures involved. The use of a custom-built fMRI compatible olfactometer will facilitate these studies.",[9,19],{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Neurodevelopment assessment","Between 12 and 18 months, the infants will undergo neurodevelopmental follow-up, during which the Bayley III assessment will be administered to evaluate any potential neurocognitive deficits.",[9,19],[45],{"name":46,"affiliation":47,"role":48},"Serafina Perrone, MD, PhD","Università di Parma","PRINCIPAL_INVESTIGATOR",[50],{"name":46,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","3388704211","+39","serafina.perrone@unipr.it",[56],{"facility":57,"status":58,"city":59,"state":10,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Azienda Ospedaliero-Universitaria di Parma","RECRUITING","Parma","43126","Italy","IT",{"type":64,"coordinates":65},"Point",[66,67],10.32618,44.79935,{"lat":67,"lon":66},[70,71,74],{"name":46,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":72,"role":73,"phone":10,"phoneExt":10,"email":10},"Virginia Beretta, PhD Student","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":10,"phoneExt":10,"email":10},"Elena Scarpa",{"type":48,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Serafina Perrone","Professor",[80],{"name":57,"class":6},"100573281","olfactory-testing-in-perinatal-asphyxia-enhancing-risk-assessment-100573281",false,"NCT06744244","Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment","Olfactory Memory in Infants With Signs of Asphyxia: An Early Indicator of Neurodevelopmental Outcomes","MEMOBRAIN","Inclusion Criteria:\n\n* Term newborns (37-41 weeks of gestational age) with signs of asphyxia at birth (cord pH \\\u003C 7.10 and\u002For BE \\> -12).\n* Maternal age \\> 18 years.\n* No medication use during pregnancy (e.g., antipsychotics, antidepressants, sedatives, anticonvulsants, anxiolytics).\n* Absence of maternal infections.\n* Apgar score \\\u003C 5 at 10 minutes of life.\n* Newborns with mild asphyxia at birth.\n* Newborns with moderate asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy, who don't need hypothermia treatment.\n* Newborns with severe asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy who don't need hypothermia treatment.\n\nExclusion Criteria:\n\n* Post-term infants (gestational age \\> 42 weeks).\n* Preterm infants (gestational age \\\u003C 37 weeks).\n* Infants with genetic syndromes or congenital anomalies.\n* Infants from mothers using drugs of abuse.\n* Infants with scalp injuries or lesions.\n* Infants with microcephaly.\n* Infants who underwent therapeutic hypothermia.","ALL","6 Hours","72 Hours",{"count":93,"type":94},30,"ESTIMATED","OBSERVATIONAL","Neonatal asphyxia remains a leading cause of neurodevelopmental disabilities despite advancements in perinatal care. Hypoxic-ischemic encephalopathy (HIE), a severe outcome of asphyxia, impacts 1-3 infants per 1,000 live births annually in industrialized nations, causing long-term neurological impairments such as cognitive dysfunction, motor deficits, and sensory impairments. Early identification of at-risk newborns is critical to initiate timely interventions and improve outcomes.\n\nOlfactory perception, crucial for newborns' adaptation to extrauterine life, involves odor identification and memory. Odor perception is known to be impaired in adults with neurological disorders and in animal models of brain injury. However, no clinical studies have assessed olfactory function in newborns with signs of asphyxia. Olfactory memory, which can be evaluated through habituation to repeated odors, may provide insights into early brain function.\n\nThis study aims to evaluate whether olfactory memory can serve as an early marker of neurodevelopmental outcomes in newborns with signs of asphyxia. By assessing physiological, behavioral, and neurological responses to olfactory stimuli, the study seeks to explore the differences between infants with mild asphyxia and those with moderate-to-severe asphyxia.",[9,98],"Moderate Birth Asphyxia",[100,101,102,103],"Perinatal Asphyxia","Hypoxic-Ischemic Encephalopathy","Biomarkers","Olfactory Function","2024-12-30",{"date":106,"type":107},"2024-12-31","ACTUAL",{"date":109,"type":107},"2024-09-10",{"date":111,"type":94},"2026-09-10",{"name":5,"class":6},1]