Clinical trial NCT06026969: Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Official title: Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lyme Disease
Post-Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Pregnancy Complications
Child Development
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Clinical Trials Network for Lyme and Other Tick-Borne Diseases
name: Steven & Alexandra Cohen Foundation
First posted: 2023-09-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

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)

Primary outcomes:
measure: Number of parent-infant dyads enrolled in the study through completion of their infant's 18-month follow-up visit
timeFrame: 7/1/2023 - 6/30/2025
Secondary outcomes:
measure: Warner Initial Developmental Evaluation (WIDEA)
timeFrame: Child ages: 2 months, 6 months, 12 months, 18 months
measure: Ages and Stages Questionnaire (ASQ)
timeFrame: Child ages: 2 months, 6 months, 12 months, 18 months
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: Child ages: 2 months, 6 months, 12 months, 18 months
measure: Infant height
timeFrame: All study visits between birth - 18 months of age
measure: Infant weight
timeFrame: All study visits between birth - 18 months of age
measure: Infant head circumference
timeFrame: Birth - 18 months of age
measure: Placental tissue analysis
timeFrame: Placenta to be collected at delivery hospital immediately after birth
measure: Analysis of parent and infant blood
timeFrame: Adult: during pregnancy between 20-38 weeks gestational age, and between infant age 2-8 weeks; Child: Between ages 2-8 weeks
measure: Fetal neuroimaging (Magnetic resonance imaging [MRI] and ultrasound) analysis
timeFrame: During pregnancy between 20-38 weeks gestational age
measure: Infant neuroimaging (Magnetic resonance imaging [MRI] and ultrasound) analysis
timeFrame: Child age: Between 2-8 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Sarah Mulkey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: