[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-opioid-withdrawal-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-opioid-withdrawal-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Neonatal Opioid Withdrawal","Neonatal Opioid Withdrawal Syndrome","Opioid Use Disorder","Intrauterine Exposure",[33,34,35],"neonatal opioid withdrawal syndrome","near infrared spectroscopy","diffuse correlation spectroscopy","RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-19","ACTUAL",{"date":42,"type":40},"2026-08-11",{"date":44,"type":22},"2027-08",{"name":46,"class":47},"Indiana University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100614344","target-trial-emulation-for-pharmacologic-treatment-of-neonatal-opioid-withdrawal-syndrome-100614344","NCT07278375","Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome","TreaT NOW","Inclusion Criteria:\n\n1. Infant is ≥ 36 weeks' gestational age\n2. Infant had antenatal opioid exposure identified by at least one of the following:\n\n   1. History of maternal opioid use during the second and\u002For third trimester of pregnancy as noted in the mother's or infant's medical record;\n   2. Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and\u002For\n   3. Positive infant toxicology screen for opioids during the initial hospital stay.\n3. The infant is being assessed and managed for NOWS at an eligible study site.\n4. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following:\n\n   * At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof\n   * At least 1 \"yes\" if assessed and managed with the Eat, Sleep, Console (ESC) care approach\n5. Infant met all inclusion criteria on or after March 25, 2024.\n\nExclusion Criteria:\n\n1. Infant has major congenital anomalies.\n2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.\n3. Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.\n4. Infant has undergone major surgical intervention prior to or at 48 hours of age.\n5. Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.\n6. Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.","0 Minutes",{"count":58,"type":22},796,"90 Days","OBSERVATIONAL","The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are:\n\n1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine?\n2. Does one treatment lead to better overall clinical outcomes than the other?\n\nResearchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly.\n\nParticipants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care.\n\nNo new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.",[29],[29,64],"NOWS","2026-02-24",{"date":67,"type":40},"2026-02-25",{"date":69,"type":40},"2025-12-09",{"date":71,"type":22},"2026-08-30",{"name":73,"class":74},"HELP for NOWS Consortium","NETWORK",22,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100511296","microrna-biomarkers-for-neonatal-opioid-withdrawal-syndrome-100511296","NCT05937594","MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome","Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence Syndrome","Inclusion Criteria:\n\n* Newborns ≥35weeks gestation with chronic in-utero opioid exposure (\\>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care\n* Neonates born at Penn State Hershey Medical Center or transferred at \\\u003C48 hours after birth\n* Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)\n\nExclusion Criteria:\n\n* \\\u003C35 week gestation\n* Infant required mechanical ventilation or non-invasive mechanical support\n* Infant exposure to magnesium sulfate\n* Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\\\u003C48hours after birth).\n* Infant with major congenital anomalies\n* Parent or guardian unable to provide consent\n* Mothers and neonates without history of opioid exposure\u002Fdependence","5 Days",{"count":85,"type":22},50,"Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.",[29,88],"Neonatal Abstinence Syndrome",[90,91,92,93,94],"microRNA","saliva","neurodevelopmental","exosomes","infant","2026-02-06",{"date":97,"type":40},"2026-02-10",{"date":99,"type":40},"2020-01-15",{"date":101,"type":22},"2027-04-10",{"name":103,"class":47},"Milton S. Hershey Medical Center"]