An observational study in Lyme Disease, Post-Treatment Lyme Disease and Chronic Lyme Disease, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Children's National Research Institute · Observational
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.
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.
91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 400 across 39 observational studies indexed under Lyme Disease.
Browse Lyme Disease studies →Children's National Research Institute is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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Pregnant participants with confirmed Borrelia burgdorferi infection or diagnosed PTLDS/Chronic Lyme will be enrolled during any trimester of pregnancy. All live-born infants will be followed to age 18 months and included in the study regardless of birth outcomes.
Exclusion Criteria:
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.
Other: Neurodevelopmental assessments and follow-up
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.
Other: Neurodevelopmental assessments and follow-up
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
Number of parent-infant dyads enrolled in the study through completion of their infant's 18-month follow-up visit
The primary outcome of this pilot study is to assess the feasibility of enrollment and longitudinal follow-up of Lyme-exposed dyads. Investigators will measure the number of parent-infant dyads who are eligible for participation, who participate in each study visit, and who successfully complete the study through infant age 18 months, throughout the duration of the study.
Time frame: 7/1/2023 - 6/30/2025
Warner Initial Developmental Evaluation (WIDEA)
Infants will be evaluated at 2, 6, 12, and 18 months of age using the Warner Initial Developmental Evaluation (WIDEA). The WIDEA is a 43-item questionnaire to assess the functional domains of self-care, motor function, communication, and social cognition in young children.
Time frame: Child ages: 2 months, 6 months, 12 months, 18 months
Ages and Stages Questionnaire (ASQ)
Infants will be evaluated at 2, 6, 12, and 18 months of age using the Ages and Stages Questionnaire (ASQ). The ASQ will assess for possible developmental delays in the domains of communication, gross motor, fine motor, problem solving, and personal adaptive skills.
Time frame: Child ages: 2 months, 6 months, 12 months, 18 months
Alberta Infant Motor Scale (AIMS)
Infants will be evaluated at 2, 6, 12, and 18 months of age using the Alberta Infant Motor Scale (AIMS). The AIMS is an observational motor assessment that can be done in-person or using telehealth.
Time frame: Child ages: 2 months, 6 months, 12 months, 18 months
Infant height
Infants' height in centimeters will be collected at each study visit.
Time frame: All study visits between birth - 18 months of age
Infant weight
Infants' height in kilograms will be collected at each study visit.
Time frame: All study visits between birth - 18 months of age
Infant head circumference
Infants' head circumference in centimeters will be collected at each study visit.
Time frame: Birth - 18 months of age
Placental tissue analysis
The placenta will be collected at birth and analyzed by an experienced placental pathologist per a standard protocol. The study team will provide the pregnant participant a letter about their study participation that they can share with their obstetrician requesting placental pathology to be performed. The study coordinator will request the paraffin embedded blocks and/or slides to be sent to Children's National for additional analysis including silver stain. Silver stain will be included to identify any spirochetes in placental tissue.
Time frame: Placenta to be collected at delivery hospital immediately after birth
Analysis of parent and infant blood
Blood will be collected at the study visit in the Lyme-exposed parent and infant to measure Lyme serology (IgM, IgG), PCR, and inflammatory cytokines. The pregnant participant will have two blood draws (one after enrollment, and one after birth) and the infant will have one blood draw at 2-8 weeks of age. The total volume of blood required for each blood draw is 2mL from the adult participant and 1.5mL from the infant.
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
Pregnant participants will receive one fetal MRI and ultrasound examinations during the second or third trimester. Fetal MRI will be performed on a GE 1.5 T scanner (General Electric, Milwaukee, WI) using an 8-channel head coil. Fetal ultrasound and MRI will be overseen and interpreted by fetal radiologists and neuroradiologists. Images will be evaluated for any structural abnormalities and for differences in brain maturation or size. The fronto-occipital and biparietal cerebral diameters, cerebellar vermis and diameter, and corpus callosum length will be measured. Biometric measurements and estimation of fetal cortical maturation will be compared with age-expected norms. Fetal ultrasound will be used to evaluate measurements of cerebral head circumference, biparietal diameter, body biometry, and interval growth between research scans. Fetal head circumference z-scores will be calculated from US measurements based on gestational age using the Hadlock method.
Time frame: During pregnancy between 20-38 weeks gestational age
Infant neuroimaging (Magnetic resonance imaging [MRI] and ultrasound) analysis
At 2-8 weeks of age, infants will have an unsedated brain MRI and a cranial ultrasound scan. Based on investigator experience, the majority of infants can have a successful brain MRI without sedation at \<6 weeks of age. The brain MRI protocol will be the standard clinical infant protocol at Children's National Hospital that includes T1, T2, susceptibility weighted imaging, and diffusion sequences. The brain MRI is without contrast.
Time frame: Child age: Between 2-8 weeks
Plan to share: No
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