Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Children's National Research Institute
40 participants
Jul 1, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06026969