Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT06026969
Status
Recruiting
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Conditions

  • Child Development
  • Chronic Lyme Disease
  • Lyme Disease
  • Post-Treatment Lyme Disease
  • Pregnancy Complications
  • Tick-Borne Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurodevelopmental assessments and follow-up — OTHER
    All infants included in this study will receive standardized neurodevelopmental assessment and neurological examinations through age 18 months.

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Meagan Williams, MSPH, CCRC
[email protected]
202-476-3388
Sarah B. Mulkey, MD, PhD (PRINCIPAL_INVESTIGATOR)
Roberta L. DeBiasi, MD, MS (SUB_INVESTIGATOR)

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