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Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

NCT06026969 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-01-07

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Clinical Trials Network for Lyme and Other Tick-Borne Diseases

    collaborator UNKNOWN

  • Steven & Alexandra Cohen Foundation

    collaborator OTHER

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Sarah Mulkey, MD, PhD · Children's National Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026969 on ClinicalTrials.gov