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Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Who can join

Ages 18 and older · All sexes

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)

About the study

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.

What is being tested

• Neurodevelopmental assessments and follow-up (other)

Sponsor: Children's National Research Institute · Participants: 40 · Started: Jul 1, 2023

Contact the study team

• Meagan Williams, MSPH, CCRC · Phone: 202-476-3388

Official record on ClinicalTrials.gov — NCT06026969

Locations in the U.S.

Conditions

• Lyme Disease
• Post-Lyme Disease Syndrome
• Tick Bites
• Tumors and Pregnancy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.