Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Children's National Research Institute
Summary
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.
Description
Childhood neurodevelopmental outcomes following antenatal Lyme disease exposure are not yet known. This pilot study will lay the groundwork for a larger study to determine the effect of in utero exposure to Lyme disease on pregnancy and early childhood neurodevelopmental outcomes. Understanding the effects on the developing brain is essential in order to inform timely prenatal and postnatal treatments to protect the fetus exposed to Lyme disease during pregnancy. Once childhood neurodevelopmental outcomes are known, appropriate follow-up and treatment guidelines can be developed to help better…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 e…
Interventions
- OtherNeurodevelopmental assessments and follow-up
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
Location
- Children's National HospitalWashington D.C., District of Columbia