Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-03 @ 12:32 AM
Study NCT ID:
NCT05937594
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva swab samples are collected from infants. Saliva samples are immediately stored at -80 for later nucleic acid extraction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurodevelopmental outcome scores', 'timeFrame': '6 months of age', 'description': 'Measured by Ages and Stages Questionnaire-3, score scale 0-60'}, {'measure': 'Maximum concentration of morphine required for withdrawal symptom control', 'timeFrame': 'Measured during the course of hospital stay', 'description': 'Measured in mg/kg/ml'}, {'measure': 'Salivary microRNA level let-7a', 'timeFrame': 'Buccal swab collected within 96 hrs of life and at discharge', 'description': 'Relative fluorescence (Cq) measured by qPCR using established housekeeping gene'}, {'measure': 'Salivary level of microRNA-146a', 'timeFrame': 'Buccal swab collected within 96 hrs of life and at discharge', 'description': 'Relative fluorescence (Cq) measured by qPCR using established housekeeping gene'}, {'measure': 'Salivary level of microRNA-192', 'timeFrame': 'Buccal swab collected within 96 hrs of life and at discharge', 'description': 'Relative fluorescence (Cq) measured by qPCR using established housekeeping gene'}, {'measure': 'Salivary level of microRNA-149-3p', 'timeFrame': 'Buccal swab collected within 96 hrs of life and at discharge', 'description': 'Relative fluorescence (Cq) measured by qPCR using established housekeeping gene'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microRNA', 'saliva', 'neurodevelopmental', 'exosomes', 'infant'], 'conditions': ['Neonatal Opioid Withdrawal Syndrome', 'Neonatal Abstinence Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<48 hours after birth\n* Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)\n\nExclusion Criteria:\n\n* \\<35 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 (\\<48hours 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/dependence'}, 'identificationModule': {'nctId': 'NCT05937594', 'briefTitle': 'MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Understanding the MicroRNA Response to Opioid Withdrawal and Their Uses As Potential Biomarkers for Neonatal Abstinence Syndrome', 'orgStudyIdInfo': {'id': '13565'}, 'secondaryIdInfos': [{'id': 'F30DA057094', 'link': 'https://reporter.nih.gov/quickSearch/F30DA057094', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants exposed to in utero opiates', 'description': 'Infants that meet IRB-approved inclusion/exclusion criteria.', 'interventionNames': ['Genetic: Buccal swab saliva for further genetic testing']}], 'interventions': [{'name': 'Buccal swab saliva for further genetic testing', 'type': 'GENETIC', 'description': 'Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.', 'armGroupLabels': ['Infants exposed to in utero opiates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'centralContacts': [{'name': 'Rhea E Sullivan, B.S.', 'role': 'CONTACT', 'email': 'rsullivan2@pennstatehealth.psu.edu', 'phone': '717-531-0003', 'phoneExt': '321585'}], 'overallOfficials': [{'name': 'Steven D. Hicks, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Steven Hicks', 'investigatorAffiliation': 'Penn State University'}}}}