Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
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
| Condition(s) | Lyme Disease, Post-Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections, Pregnancy Complications, Child Development |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 permi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Children's National Research Institute |
| Locations | Washington D.C., District of Columbia, United States |
| Start date | 2023-07-01 |
| NCT ID | NCT06026969 |
| Official listing | https://clinicaltrials.gov/study/NCT06026969 |