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
Researchers are investigating the neurodevelopmental outcomes in fetuses and infants exposed to Lyme disease during pregnancy. This pilot study aims to evaluate the feasibility of long-term monitoring of these children to understand how in utero exposure to Lyme disease and Post-Treatment Lyme Disease Syndrome (PTLDS) might affect early brain development. The findings will help guide future larger studies and inform prenatal and postnatal care to support affected children's developmental needs. Pregnant participants diagnosed with Lyme disease or PTLDS will undergo fetal MRI and ultrasound scans during the second or third trimester. After birth, infants will receive brain MRI and cranial ultrasound without sedation. The placenta will be collected for analysis, and parent and infant blood samples will be tested for Lyme disease antibodies and inflammation markers. Optional interviews with mothers will collect additional information about their pregnancy experiences. Infants will also have standardized neurodevelopmental assessments and neurological exams through 18 months of age. Throughout the study, researchers will collect detailed data via questionnaires covering medical history, nutrition, breastfeeding, and socioeconomic factors. Participants will be followed from pregnancy through the infant's first 18 months, with multiple evaluations to track development and health. The main outcome measured is the number of parent-infant pairs completing the full 18-month follow-up to assess the study's feasibility and gather preliminary data for future research.
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
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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
S
Sarah Mulkey, MD, PhD
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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