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Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Recruitingn/aAges 18 Years - anyAllChildren's National Research Institute
NCT06026969 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Neurodevelopmental assessments and follow-up
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Where

1 site
Children's National Hospital
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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