Status:
RECRUITING
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Clinical Trials Network for Lyme and Other Tick-Borne Diseases
Steven & Alexandra Cohen Foundation
Conditions:
Lyme Disease
Post-Treatment Lyme Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 Po...
Detailed Description
Childhood neurodevelopmental outcomes following antenatal Lyme disease exposure are not yet known. This pilot study will lay the groundwork for a larger study to determine the effect of in utero expos...
Eligibility Criteria
Inclusion
- English speaker
- Currently reside in the United States or Canada
- Meet CDC criteria for: (1) clinical and/or laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS/Chronic Lyme within 3 years of current pregnancy
- Able to be contacted for follow-up
Exclusion
- Intellectually unable to comprehend study procedures
- Health issues or metallic implant that precludes undergoing MRI
- 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)
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06026969
Start Date
July 1 2023
End Date
June 1 2025
Last Update
January 7 2025
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010