Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Status: Recruiting
Location: See location...
Intervention Type: Other
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Meagan Williams, MSPH, CCRC
mewilliams@childrensnational.org
202-476-3388
Backup
Sarah Mulkey, MD, PhD
sbmulkey@childrensnational.org
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 40
Treatments
Lyme disease
Pregnant participants in the Lyme disease cohort will meet CDC criteria for clinical and/or laboratory diagnosis of Lyme disease during pregnancy based on stage of disease. Participants will be enrolled following confirmation that they have been diagnosed by a medical professional per CDC guidelines.~Participants in this cohort may be enrolled during any trimester of pregnancy. Live-born infants will be included in the cohort and followed through age 18 months.
Post-treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme
Pregnant participants in the PTLDS/Chronic Lyme cohort will have been diagnosed with PTLDS/Chronic Lyme by a health care provider no less than 6 months, but no greater than 3 years, prior to enrollment. Participants will be enrolled following confirmation that they have been diagnosed by a medical professional per CDC guidelines.~Participants in this cohort may be enrolled during any trimester of pregnancy. Live-born infants will be included in the cohort and followed through age 18 months.
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute
Collaborators: Steven & Alexandra Cohen Foundation, Clinical Trials Network for Lyme and Other Tick-Borne Diseases