[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518163":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lyme disease",null,"Pregnant participants in the \"Lyme disease\" cohort will meet CDC criteria for clinical and\u002For laboratory diagnosis of Lyme disease during pregnancy based on stage of disease. Participants will be enrolled following confirmation that they have been diagnosed by a medical professional per CDC guidelines.\n\nParticipants in this cohort may be enrolled during any trimester of pregnancy. Live-born infants will be included in the cohort and followed through age 18 months.",[13],"Other: Neurodevelopmental assessments and follow-up",{"label":15,"type":10,"description":16,"interventionNames":17},"Post-treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme","Pregnant participants in the \"PTLDS\u002FChronic Lyme\" cohort will have been diagnosed with PTLDS\u002FChronic Lyme by a health care provider no less than 6 months, but no greater than 3 years, prior to enrollment. Participants will be enrolled following confirmation that they have been diagnosed by a medical professional per CDC guidelines.\n\nParticipants in this cohort may be enrolled during any trimester of pregnancy. Live-born infants will be included in the cohort and followed through age 18 months.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Neurodevelopmental assessments and follow-up","All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.",[9,15],[24],{"name":25,"affiliation":5,"role":26},"Sarah Mulkey, MD, PhD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Meagan Williams, MSPH, CCRC","CONTACT","202-476-3388","mewilliams@childrensnational.org",{"name":25,"role":30,"phone":10,"phoneExt":10,"email":34},"sbmulkey@childrensnational.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-77.03637,38.89511,{"lat":48,"lon":47},[51,52,54],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},{"name":53,"role":26,"phone":10,"phoneExt":10,"email":10},"Sarah B. Mulkey, MD, PhD",{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Roberta L. DeBiasi, MD, MS","SUB_INVESTIGATOR",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60,63],{"name":61,"class":62},"Clinical Trials Network for Lyme and Other Tick-Borne Diseases","UNKNOWN",{"name":64,"class":6},"Steven & Alexandra Cohen Foundation","100518163","pregnancy-and-early-neurodevelopmental-outcomes-following-in-utero-lyme-disease-exposure-100518163",false,"NCT06026969","Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure","Inclusion Criteria:\n\n* English speaker\n* Currently reside in the United States or Canada\n* Meet CDC criteria for: (1) clinical and\u002For laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS\u002FChronic Lyme within 3 years of current pregnancy\n* Able to be contacted for follow-up\n\nExclusion Criteria:\n\n* Intellectually unable to comprehend study procedures\n* Health issues or metallic implant that precludes undergoing MRI\n* Incapable of completing study requirements (note: inability to travel to Children's National for in-person follow-up \\[for example, due to bedrest, travel restrictions, or financial inability to travel\\] is NOT an exclusion criterion; any interested and eligible participants requiring \"remote only\" participation will be permitted to join the study and complete all requirements besides in-person follow-up)","ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","OBSERVATIONAL","The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.",[79,80,81,82,83,84],"Lyme Disease","Post-Treatment Lyme Disease","Chronic Lyme Disease","Tick-Borne Infections","Pregnancy Complications","Child Development","2026-06-15",{"date":87,"type":88},"2026-06-16","ACTUAL",{"date":90,"type":88},"2023-07-01",{"date":92,"type":75},"2026-12",{"name":5,"class":6},1]