Assessing neurodevelopmental outcomes in infants exposed to Lyme disease during pregnancy
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
This study is trying to see how being exposed to Lyme disease during pregnancy affects the brain development of babies from birth to 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06026969 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women diagnosed with Lyme disease or PTLDS within three years prior to their pregnancy.
Not a fit: Patients who do not have a diagnosis of Lyme disease or PTLDS, or those unable to participate due to health issues preventing MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of neurodevelopmental outcomes in children exposed to Lyme disease during pregnancy.
How similar studies have performed: While there is limited research specifically on neurodevelopmental outcomes following in utero Lyme disease exposure, this pilot study addresses a priority research area that has not been extensively explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.