Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how Lyme disease, which is often caused by tick bites, can affect the development of babies while they are still in the womb and after they are born. Specifically, the researchers want to see how infants who were exposed to Lyme disease during pregnancy grow and develop during their first 18 months of life. They are looking for pregnant women who either have Lyme disease or a condition called Post-Treatment Lyme Disease Syndrome (PTLDS) to participate in the study.

To be eligible, participants need to be English speakers living in the United States or Canada and must have been diagnosed with Lyme disease during their current pregnancy or with PTLDS/Chronic Lyme within the last three years. The study will involve monitoring the pregnancies and assessing the babies' development through regular check-ins. Even if someone is unable to travel for in-person visits, they can still join the study and participate remotely. This research aims to better understand the potential impacts of Lyme disease on both mothers and their children, helping to improve care and support for affected families.

Gender

ALL

Eligibility 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)