Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurodevelopmental assessments and follow-up.
- Who it may be relevant to
- Registry conditions: Lyme Disease, Post-Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Childhood neurodevelopmental outcomes following antenatal Lyme disease exposure are not yet known. This pilot study will lay the groundwork for a larger study to determine the effect of in utero exposure to Lyme disease on pregnancy and early childhood neurodevelopmental outcomes. Understanding the effects on the developing brain is essential in order to inform timely prenatal and postnatal treatments to protect the fetus exposed to Lyme disease during pregnancy. Once childhood neurodevelopmental outcomes are known, appropriate follow-up and treatment guidelines can be developed to help better support children's developmental needs.
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.
Interventions
- Other 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 measures
- 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]
Secondary outcome measures (10)
- Warner Initial Developmental Evaluation (WIDEA) [Time frame: Child ages: 2 months, 6 months, 12 months, 18 months]
- Ages and Stages Questionnaire (ASQ) [Time frame: Child ages: 2 months, 6 months, 12 months, 18 months]
- Alberta Infant Motor Scale (AIMS) [Time frame: Child ages: 2 months, 6 months, 12 months, 18 months]
- Infant height [Time frame: All study visits between birth - 18 months of age]
- Infant weight [Time frame: All study visits between birth - 18 months of age]
- Infant head circumference [Time frame: Birth - 18 months of age]
- Placental tissue analysis [Time frame: Placenta to be collected at delivery hospital immediately after birth]
- Analysis of parent and infant blood [Time frame: Adult: during pregnancy between 20-38 weeks gestational age, and between infant age 2-8 weeks; Child: Between ages 2-8 weeks]
- Fetal neuroimaging (Magnetic resonance imaging [MRI] and ultrasound) analysis [Time frame: During pregnancy between 20-38 weeks gestational age]
- Infant neuroimaging (Magnetic resonance imaging [MRI] and ultrasound) analysis [Time frame: Child age: Between 2-8 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Identifiers
NCT: NCT06026969 · 00000425