[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06415994":3,"trial-entities:NCT06415994":128,"trial-summary:NCT06415994":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":29,"primary_purpose":16,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":60,"secondary_outcomes":68,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":103,"locations":106,"central_contacts":124,"overall_officials":125,"references":126,"see_also_links":127},"NCT06415994","STUDY23110104","Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder","ENROLLING_BY_INVITATION","2029-12-01","2026-07","2026-07-14","2024-02-13","Senthil Sadhasivam","OTHER",false,"The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:\n\n* Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.\n* To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.\n\nIn this study participants will:\n\n* Receive two placental-fetal MRIs, one during second trimester and one in third trimester.\n* Answer surveys relating to their medical and social history.\n* Have blood drawn during pregnancy and delivery.\n* Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.",null,[18,19,20,21,22,23],"Opioid Use Disorder","Substance-Related Disorders","Pregnancy Related","Narcotic-Related Disorders","Buprenorphine Dependence","Methadone Dependence",[25,18,26,27,28],"Pregnant with Opioid Use Disorder","Subutex","Buprenorphine","Pregnant taking buprenorphine\u002Fsubutex","OBSERVATIONAL",[],{"count":32,"type":33},250,"ESTIMATED",[35,41,47,52,56],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Buprenorphine or Methadone Treatment","Pregnant mothers must be taking Buprenorphine or Methadone",[40],"Pregnant Mothers with Opioid Use Disorder",{"type":42,"name":43,"description":44,"armGroupLabels":45},"DIAGNOSTIC_TEST","Fetal and Placental MRI","Two MRIs :\n\n* Second Trimester\n* Third Trimester",[46,40],"Pregnant Mothers",{"type":48,"name":49,"description":50,"armGroupLabels":51},"BEHAVIORAL","Child Developmental Assessment","At 1 year of life child will receive a developmental assessment",[46,40],{"type":48,"name":53,"description":54,"armGroupLabels":55},"Questionnaires","Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development",[46,40],{"type":13,"name":57,"description":58,"armGroupLabels":59},"Blood and Placental Samples","At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.\n\nAt delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.",[46,40],[61,65],{"measure":62,"description":63,"timeFrame":64},"Alterations in fetal brain volume","Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls","Between 20 weeks gestation and delivery",{"measure":66,"description":67,"timeFrame":64},"Differences in placenta signal","Comparing differences in placenta signal using MRI between the POE group and controls",[69,72,75,79,82,85],{"measure":70,"description":71,"timeFrame":64},"Placental epigenetic changes related to POE","Compare placental DNA methylation in POE group and control group",{"measure":73,"description":74,"timeFrame":64},"Placental dysfunction biomarkers related to POE","Compare concentrations of blood proteins in POE group vs controls",{"measure":76,"description":77,"timeFrame":78},"Neonatal Opioid Withdrawal Syndrome (NOWS) severity","Measuring NOWs severity in the POE group using eat sleep console scores","After birth through one year of life",{"measure":80,"description":81,"timeFrame":78},"Length of Hospital Stay","Measuring NOWs severity in the POE group using length of hospital stay",{"measure":83,"description":84,"timeFrame":78},"Ages and Stages Questionnaire Scores during infancy","Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.",{"measure":86,"description":87,"timeFrame":78},"Neurocognitive and behavioral development assessment (Bayley-4) at one year of age","Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.","FEMALE","18 Years","100 Years",true,{"inclusion":93,"exclusion":98,"raw_text":102},[94,95,96,97],"Age \\>18 years","Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program","Singleton Pregnancy","Planned delivery at Indiana University or University of Pittsburgh study sites",[99,100,101],"Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures","Known or suspected major fetal\u002F neonatal congenital abnormalities","HIV or AIDS","Pregnant women with opioid use disorder\n\nInclusion Criteria:\n\n* Age \\>18 years\n* Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program\n* Singleton Pregnancy\n* Planned delivery at Indiana University or University of Pittsburgh study sites\n\nExclusion Criteria:\n\n* Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures\n* Known or suspected major fetal\u002F neonatal congenital abnormalities\n* HIV or AIDS\n\nInfants with prenatal opioid exposure:\n\nInclusion:\n\n1. Prenatal buprenorphine or methadone exposure\n2. Born to mother enrolled in Opioid Use Disorder arm of study\n\nExclusion:\n\nMajor congenital anomalies or genetic syndromes affecting neurodevelopment\n\nControl Pregnant Women:\n\nInclusion:\n\n1. Women \\>18 Years of age\n2. Healthy singleton pregnancy\n3. Planned delivery at Indiana University or University of Pittsburgh study sites\n\nExclusion:\n\n1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures\n2. HIV or AIDS\n3. Known or suspected major fetal congenital abnormalities\n4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.\n\nControl infants:\n\nInclusion:\n\nBorn to control pregnant mother enrolled in study\n\nExclusion:\n\nAny major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.",[104,105],"ADULT","OLDER_ADULT",[107,116],{"facility":108,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Riley Hospital for Children","Indianapolis","Indiana","46202","United States",{"lat":114,"lon":115},39.76838,-86.15804,{"facility":117,"city":118,"state":119,"zip":120,"country":112,"geoPoint":121},"University of Pittsburgh","Pittsburgh","Pennsylvania","15260",{"lat":122,"lon":123},40.44062,-79.99589,[],[],[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[18,130],"Pregnancy",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]