Study of Pregnancy and Early Brain Development in Babies Exposed to Lyme Disease Before Birth

What this Trial Is About

This research aims to evaluate the feasibility of monitoring neurodevelopment over time in fetuses and infants exposed to Lyme disease during pregnancy. It focuses on pregnant individuals diagnosed with Lyme disease or Post-Treatment Lyme Disease Syndrome PTLDS and follows their pregnancies and infants until 18 months of age. The study addresses a knowledge gap about the effects of in utero Lyme disease exposure on early childhood development, intending to inform future treatment guidelines. Pregnant participants diagnosed with Lyme disease or PTLDS will undergo fetal MRI and ultrasound scans during the second or third trimester. Optional interviews during the third trimester will collect additional information about their experiences. At birth, placental tissue will be collected for analysis, and blood samples from parents and infants will be tested for Lyme disease markers and inflammation. After birth, infants will receive unsedated brain MRI and cranial ultrasound, along with repeated developmental evaluations and neurological exams up to 18 months. Participants will complete questionnaires covering medical history, nutrition, breastfeeding, and socioeconomic factors throughout the study. Researchers will measure developmental progress using standardized tools like the Warner Initial Developmental Evaluation and Ages and Stages Questionnaire at multiple ages. They will also monitor infant growth through measurements such as height, weight, and head circumference. The study aims to enroll and follow parent-infant pairs through their infants 18-month visit, ensuring comprehensive data collection and safety monitoring.

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure