Pilot Study Recruitment: Pregnant Women with Lyme

Children’s National Hospital – Congenital Infection Program has launched a pilot study being led by Sarah Mulkey, MD, PhD, “Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure.” This study is funded by the Clinical Trials Network for Lyme and Other Tick-borne Diseases which is supported by a grant from the Steven & Alexandra Cohen Foundation, the largest private funder of Lyme and tick-borne disease research in the country.

This pilot study will assess the feasibility of evaluation for outcomes of pregnancies of women affected by Lyme disease infection. Researchers will assess the brain development of fetuses and children who were exposed to Lyme disease in utero and will follow the development of infants from birth to age 18 months. This study is currently recruiting pregnant women with Lyme disease, Post-Treatment Lyme Disease Syndrome (PTLDS)/Chronic Lyme disease for participation.

Anticipated enrollment will include 40 pregnant women. “Lyme disease” cohorts will be pregnant women that have been diagnosed with Lyme by a medical professional and the CDC criteria for clinical and/or laboratory diagnosis of Lyme disease. “Chronic PTLDS/Chronic Lyme” cohorts are required to be diagnosed by a medical care provider “no less than 6 months, but no greater than 3 years” prior to enrollment and must meet the same requirements of CDC guidelines for diagnosis. Cohorts in both groups may be enrolled during any trimester of pregnancy. Live-born infants in the study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.

The study is actively recruiting pregnant volunteers to participate in questionnaires, one fetal MRI and ultrasound, one infant MRI and ultrasound, two in-person neurology evaluations, and two blood draws  Lyme in Pregnancy Study Participant Sign-Up Link.

Important changes to the study as of December 2023:

• All participants will be reimbursed for their travel up to 230 miles each way for each in-person visit to to Washington, DC for in-person study visits.
• Compensation for participants has been increased for both in-person and remote study visits.
• An additional qualitative study will be initiated in 2024 to help guide future research on child and family outcomes after congenital Lyme exposure.
• Clinicians who refer their patients patients who are subsequently enrolled in the study will opportunity to join the Lyme in Pregnancy Working Group.
• Resources in the Recruitment Toolkit have been updated to reflect these changes.

For questions about these updates, please email Meagan at [email protected].

*Dr. Brian Fallon, M.D., M,P,H, Director, Columbia University Irving Medical Center, is leading the first national Clinical Trials Network Coordinating Center (CTNCC) for Lyme and other Tick-borne Diseases with the goal to identify more effective treatments for patients with Lyme and other tick-borne diseases.

For More Information: 

Children’s National Study: Printable Flyer

Children’s National Study: Participant Inclusion Flowchart

Children’s National Hospital- Congenital Infection Program

ClinicalTrials.gov 

Email the study team at: [email protected]

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