[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-abstinence-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-abstinence-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100560375","an-intervention-mapping-approach-to-closing-the-gap-in-maternal-oud-and-infant-nas-care-support-100560375",false,"NCT06576323","An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)","An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care","SUPPORT","Inclusion Criteria for Interview Participants in Aim 1:\n\n* Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker.\n* Participants should provide direct care to NICU patients and\u002For their mothers\n* Participants should be proficient in English language\n* Participants should have access to a computer with internet connectivity or phone\n\nInclusion Criteria for Mothers in Aim 1:\n\n* Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS\n* Participants should be diagnosed with opioid use disorder\n\nInclusion Criteria for Clinicians in Aim 3:\n\n* See above for inclusion criteria for interview participants.\n* We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3.\n\nInclusion Criteria for Mothers in Aim 3:\n\n* Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH)\n* Participants should be no more than 4 weeks postpartum\n* Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine\n\nExclusion Criteria for Interview Participants in Aim 1:\n\n\\- None\n\nExclusion Criteria for Mothers in Aim 1:\n\n\\- None\n\nExclusion Criteria for Clinicians in Aim 3:\n\n\\- None\n\nExclusion Criteria for Mothers in Aim 3:\n\n\\- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed",true,"ALL","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs.\n\nFirst, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders.\n\nThe goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.",[28,29],"Opioid Use Disorder","Neonatal Abstinence Syndrome","RECRUITING","2026-07-02",{"date":33,"type":34},"2026-07-06","ACTUAL",{"date":36,"type":34},"2024-07-01",{"date":38,"type":22},"2027-05-31",{"name":40,"class":41},"University of Pennsylvania","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"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","1 Day","5 Days",{"count":21,"type":22},"OBSERVATIONAL","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.",[55,29],"Neonatal Opioid Withdrawal Syndrome",[57,58,59,60,61],"microRNA","saliva","neurodevelopmental","exosomes","infant","2026-02-06",{"date":64,"type":34},"2026-02-10",{"date":66,"type":34},"2020-01-15",{"date":68,"type":22},"2027-04-10",{"name":70,"class":41},"Milton S. Hershey Medical Center",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":71},"100456671","the-alberta-neonatal-abstinence-syndrome-mother-baby-care-improvement-program-100456671","NCT05226624","The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program","The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT (NASCENT) Program: A Stepped Wedge Cluster Randomized Trial of a Hospital-level Neonatal Abstinence Syndrome Intervention","NASCENT","Inclusion Criteria:\n\n* Infants born at \\>36 weeks gestation to mothers who report opiate use during pregnancy (or who are in an ODP\u002FVODP program) and who are admitted to a participating implementation project hospital.\n\nExclusion Criteria:\n\n* Infants born at less than 36 weeks and\u002For birth weight less than 2000 grams and infants with congenital anomalies will be excluded as these infants would be expected to be admitted to NICU.","FEMALE",{"count":82,"type":22},240,[25],"Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years. Babies with NAS can be very difficult to care for with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of mothers and babies at a time when it is most important that they be together. This separation is traumatic for families and expensive for the health and foster care systems, as babies often end up being cared for by governmental agencies. Recent research has shown that keeping mothers and babies together in a quiet, supportive environment in hospital, called 'rooming in', leads to a decreased need for NICU admission, decreased amount of time spent in the NICU, increased rates of breastfeeding, and an increase in babies going home with their mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in Alberta to determine if the investigators can improve NAS care provided to babies and mothers. The goal is to decrease NICU admission and length of stay, increase the number of babies going home with mothers, increase breastfeeding rates, and increase the number of women enrolled in supportive programs for substance use. The investigators will also determine if this rooming-in model of care decreases health and societal costs associated with caring for babies with NAS.",[29],[29,87,88,89],"Implementation Science","Rooming-in Care","Opioid Replacement Therapy","2025-09-16",{"date":92,"type":34},"2025-09-17",{"date":94,"type":34},"2023-10-01",{"date":96,"type":22},"2026-11-30",{"name":98,"class":41},"University of Alberta"]