Recruiting

Observational Study

Sponsor:

Children's National Research Institute

Code:

NCT06026969

Conditions

Lyme Disease

Post-Treatment Lyme Disease

Chronic Lyme Disease

Tick-Borne Infections

Pregnancy Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurodevelopmental assessments and follow-up

Study Details

Brief 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.

Conditions

Lyme Disease

Post-Treatment Lyme Disease

Chronic Lyme Disease

Tick-Borne Infections

Pregnancy Complications

Study ID

NCT06026969

Start date

Jul 1, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Neurodevelopmental assessments and follow-up

All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.

Primary outcome measure

  • Number of parent-infant dyads enrolled in the study through completion of their infant's 18-month follow-up visit [ Time Frame: 7/1/2023 - 6/30/2025 ]

Central Contacts and Locations

Central contacts

Meagan Williams, MSPH, CCRC

202-476-3388mewilliams@childrensnational.org

Sarah Mulkey, MD, PhD

sbmulkey@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Meagan Williams, MSPH, CCRC

202-476-3388mewilliams@childrensnational.org

Principal Investigator:

Sarah B. Mulkey, MD, PhD

More Information

Sponsor

Children's National Research Institute

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-06-16.