Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
NCT ID: NCT06026969
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2023-07-01
2025-06-30
Brief Summary
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Detailed Description
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The primary aim of this study is to assess the feasibility of longitudinal follow-up of fetuses and infants exposed to Lyme disease in utero.Lyme disease in pregnancy and the impact on the fetus/child following in utero exposure has been identified as a priority research area; this pilot study is the essential step to plan a large study that will fill this knowledge gap and make a substantial contribution to the field.
The investigators will perform a prospective pilot longitudinal cohort study of B. burgdorferi-infected parents and their in-utero-exposed fetuses/infants. Patients included in this study will have a clinical diagnosis of Lyme disease during gestation or have been diagnosed with Lyme disease and/or PTLDS within 3 years preceding pregnancy.
Pregnant participants will receive a fetal MRI and ultrasound during the second or third trimesters of gestation. The investigators will conduct optional qualitative interviews with interested participants during their 3rd trimester to gather additional data on their experiences with Lyme disease/PTLDS during pregnancy. The placenta will be collected at birth and analyzed by an experienced placental pathologist per a standard protocol. Parent and infant blood will be tested for Lyme disease serology and markers of inflammation.
Following birth, infants will receive an unsedated brain MRI and a cranial ultrasound. The investigators will complete serial developmental evaluations using standardized assessments at multiple timepoints through age 18 months and receive neurological examinations. Throughout the study, participants will also be asked to complete questionnaires including but not limited to topics such as medical history, nutrition, breastfeeding, and socioeconomic information.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Neurodevelopmental assessments and follow-up
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations 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.
Neurodevelopmental assessments and follow-up
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
Interventions
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Neurodevelopmental assessments and follow-up
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Clinical Trials Network for Lyme and Other Tick-Borne Diseases
UNKNOWN
Steven & Alexandra Cohen Foundation
OTHER
Children's National Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sarah Mulkey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Participant enrollment screener
Other Identifiers
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00000425
Identifier Type: -
Identifier Source: org_study_id
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