Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Description

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 Overview

Study Details

Study overview

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.

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Condition
Lyme Disease
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's National Research Institute,

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

Study Record Dates

2025-06