Lyme DiseaseNCT06026969
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
An observational study of Lyme Disease and Post-Treatment Lyme Disease, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Disease, Post-Treatment Lyme Disease, Chronic Lyme Disease
- What is being tested?
- Neurodevelopmental assessments and follow-up
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Mulkey, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Meagan Williams, MSPH, CCRC, 202-476-3388, mewilliams@childrensnational.org
Sarah B. Mulkey, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Lyme Disease, Post-Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections, Pregnancy Complications, Child Development
- Being tested
- Neurodevelopmental assessments and follow-up
- Medical subject headings
- Lyme Disease, Post-Lyme Disease Syndrome, Tick-Borne Diseases, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessments and follow-upOther
All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurodevelopmental assessments and follow-up | |
| 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. Receives: Other: Neurodevelopmental assessments and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7/1/2023 - 6/30/2025
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Child ages: 2 months, 6 months, 12 months, 18 months
Infant height
Infants' height in centimeters will be collected at each study visit.
Measured: All study visits between birth - 18 months of age
Infant weight
Infants' height in kilograms will be collected at each study visit.
Measured: All study visits between birth - 18 months of age
Infant head circumference
Infants' head circumference in centimeters will be collected at each study visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Child age: Between 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Network for Lyme and Other Tick-Borne Diseases, Steven & Alexandra Cohen Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah Mulkey, MD, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026969
- Sponsor's protocol ID
- 00000425
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No