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Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
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.
Conditions:
🦠 Lyme Disease 🦠 Post-Treatment Lyme Disease 🦠 Chronic Lyme Disease 🦠 Tick-Borne Infections 🦠 Pregnancy Complications 🦠 Child Development
🗓️ Study Start (Actual) 1 July 2023
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 40
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 August 2023
  • First Submitted that Met QC Criteria 5 September 2023
  • First Posted 7 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 September 2023
  • Last Update Posted 7 September 2023
  • Last Verified September 2023
I'm interested ...!!