[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638947":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":28,"maxAge":82,"enrollmentInfo":83,"targetDuration":28,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":47,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Prenatal opioid exposure (POE)","EXPERIMENTAL","A total of 20 newborns with prenatal opioid exposure will have daily bedside FD-NIRS\u002FDCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).",[13],"Device: FD-NIRS and DCS",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy control","A total of 20 healthy age-matched newborns will have daily bedside FD-NIRS\u002FDCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Pharmacologic Treatment","A group of 6 newborns with POE who are treated pharmacologically for severe neonatal opioid withdrawal syndrome will have daily bedside FD-NIRS\u002FDCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","FD-NIRS and DCS","The investigators will use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2).",[15,19,9],null,[30,33],{"name":31,"affiliation":5,"role":32},"Anna Thomas, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Silvina Ferradal, PhD",[36,40],{"name":31,"role":37,"phone":38,"phoneExt":28,"email":39},"CONTACT","3179081096","aeschwar@iu.edu",{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},"Hannah Rykovich, RN","3174740725","hsrakow@iu.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Indiana University - Riley Hospital for Children","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.15804,39.76838,{"lat":57,"lon":56},[60,63],{"name":61,"role":37,"phone":62,"phoneExt":28,"email":39},"Anna Thomas","317-908-1096",{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"type":32,"investigatorFullName":61,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Assistant Professor",[67,69],{"name":68,"class":6},"Indiana Clinical and Translational Sciences Institute",{"name":70,"class":71},"National Institute on Drug Abuse (NIDA)","NIH","100638947","cerebral-physiology-of-nows-100638947",false,"NCT07610746","Cerebral Physiology of NOWS","Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.","NIRS for NOWS","Inclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n* History of prenatal opioid exposure\n\nControl infants:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n\nMothers of infants with prenatal opioid exposure:\n\n* greater or equal to 19 years of age\n* Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or illicit opioids\n\nMothers of control infants:\n\n* greater than or equal to 19 years of age\n\nExclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n\nControl infants:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n* Any history of prenatal opioid exposure\n\nMothers of infants with prenatal opioid exposure:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n\nMothers of control infants:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n* Tobacco, SSRI or any opioid use during pregnancy",true,"ALL","1 Day",{"count":84,"type":85},46,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.",[91,92,93,94],"Neonatal Opioid Withdrawal","Neonatal Opioid Withdrawal Syndrome","Opioid Use Disorder","Intrauterine Exposure",[96,97,98],"neonatal opioid withdrawal syndrome","near infrared spectroscopy","diffuse correlation spectroscopy","2026-08-18",{"date":101,"type":102},"2026-08-19","ACTUAL",{"date":104,"type":102},"2026-08-11",{"date":106,"type":85},"2027-08",{"name":5,"class":6},1]