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Observational Study: Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

This study is looking at the health and development of babies whose mothers had Lyme disease during pregnancy. Researchers want to see if it's possible to follow these babies from birth until they are 18 months old to understand how Lyme disease exposure before birth might affect their early development. You can join if you are pregnant, speak English, live in the US or Canada, and have a diagnosis of Lyme disease during your current pregnancy or within three years before your current pregnancy. The main goal is to see how many parent-infant pairs can complete the study through the infant's 18-month follow-up visit. This is an observational study, meaning no specific treatments are being tested, but rather the natural course of development is being observed.

Study design
This is an observational study planning to enroll 40 participants. It is a pilot study, meaning it's a smaller study to help plan a larger one in the future.
What's involved
If you participate, your pregnancy will be monitored, and your baby will receive standardized neurodevelopmental assessments and neurological exams from birth until 18 months of age.
Compensation
Not stated in the trial record.
Follow-up
Infants will be followed until they are 18 months old.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06026969

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Recruiting
Not specifiedAges 18+Observational
Children's National Research Institute
~40 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Neurodevelopmental assessments and follow-up

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of parent-infant dyads enrolled in the study through completion of their infant's 18-month follow-up visit
Measured over 7/1/2023 - 6/30/2025

Conditions

Lyme Disease
Post-Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Pregnancy Complications
Child Development

Explore related trials

Borrelia Burgdorferi InfectionPost-Treatment Lyme Disease Syndrome

NCT06026969

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's National Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sarah Mulkey, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

Meagan Williams, MSPH, CCRC
[email protected]
202-476-3388
Email the study team

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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)

What this trial measures

  • Number of parent-infant dyads enrolled in the study through completion of their infant's 18-month follow-up visit7/1/2023 - 6/30/2025

    The primary outcome of this pilot study is to assess the feasibility of enrollment and longitudinal follow-up of Lyme-exposed dyads. Investigators will measure the number of parent-infant dyads who are eligible for participation, who participate in each study visit, and who successfully complete the study through infant age 18 months, throughout the duration of the study.