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
N/A
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 impact of Lyme disease exposure during pregnancy on the early brain development of babies. This pilot study focuses on evaluating the neurodevelopment of fetuses and infants whose parents had Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) during pregnancy. The study aims to understand how in utero exposure to Lyme disease might affect childhood development and to prepare for a larger study that could guide better prenatal and postnatal care. Pregnant participants diagnosed with Lyme disease or PTLDS will be enrolled at any stage of pregnancy. They will undergo fetal MRI and ultrasound scans during their second or third trimester. Placental tissue will be collected at birth for analysis, and blood samples from both parent and infant will be tested for Lyme disease and inflammation markers. After birth, infants will receive brain MRI and cranial ultrasound scans, along with neurodevelopmental assessments and neurological exams through 18 months of age. Throughout the study, parents will provide information via questionnaires about medical history, nutrition, breastfeeding, and socioeconomic factors. Infants will have regular developmental evaluations at 2, 6, 12, and 18 months. The study measures include enrollment completion rates, developmental milestones, infant growth, and imaging results. This longitudinal follow-up will help determine the feasibility of tracking neurodevelopment after in utero Lyme disease exposure over time.
CONDITIONS
Brief 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...
- Unable to understand study procedures due to intellectual limitations
- Health issues or metallic implants that prevent undergoing MRI
- Unable to complete study requirements (note: inability to travel for in-person visits is not an exclusion; remote participation is allowed for those eligible)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility confirmation
Duration - During pregnancy between 20-38 weeks gestational age
Participants receive fetal MRI and ultrasound during pregnancy to assess fetal development and exposure effects.
1 to 2 visits during second or third trimester
Duration - At birth and between infant age 2-8 weeks
Placenta is collected at birth and parent and infant blood samples are taken to analyze Lyme disease markers and inflammation.
1 visit at birth and 1 visit for blood collection between 2-8 weeks post-birth
Duration - Between infant age 2-8 weeks
Infants receive an unsedated brain MRI and cranial ultrasound to assess early neurodevelopment.
1 to 2 visits for infant brain MRI and ultrasound
Duration - Birth through 18 months of age
Participants complete standardized neurodevelopmental assessments, neurological exams, and questionnaires through age 18 months to monitor child development.
4 to 5 visits at approximately 2, 6, 12, and 18 months
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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