Actively Recruiting
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Led by Children's National Research Institute · Updated on 2025-01-07
40
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
C
Clinical Trials Network for Lyme and Other Tick-Borne Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaker
- Currently reside in the United States or Canada
- Meet CDC criteria for clinical and/or laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR clinical diagnosis of PTLDS/Chronic Lyme within 3 years of current pregnancy
- Able to be contacted for follow-up
You will not qualify if you...
- Intellectually unable to understand study procedures
- Health conditions or metallic implants that prevent undergoing MRI
- Unable to complete study requirements (inability to travel for in-person visits is allowed if remote participation is possible)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
M
Meagan Williams, MSPH, CCRC
CONTACT
S
Sarah Mulkey, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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