Assessing neurodevelopmental outcomes in infants exposed to Lyme disease during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the feasibility of longitudinal neurodevelopmental assessments for fetuses and infants exposed to Lyme disease in utero. Pregnant participants diagnosed with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be monitored throughout their pregnancy, and their infants' development will be assessed from birth until 18 months of age. The study seeks to understand the impact of in utero Lyme disease exposure on early childhood neurodevelopment, which is crucial for developing appropriate follow-up and treatment guidelines. This foundational research will inform larger studies aimed at addressing this significant knowledge gap.

Why it matters

Who can join: the full rules

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)

Where it's running

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Sarah Mulkey, MD, PhD — Children's National Research Institute
• Study coordinator: Meagan Williams, MSPH, CCRC
• Email: mewilliams@childrensnational.org
• Phone: 202-476-3388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.