RECRUITING

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Quick Facts

Study Start:2023-07-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06026969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaker
  2. * Currently reside in the United States or Canada
  3. * 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
  4. * Able to be contacted for follow-up
  1. * Intellectually unable to comprehend study procedures
  2. * Health issues or metallic implant that precludes undergoing MRI
  3. * 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)

Contacts and Locations

Study Contact

Meagan Williams, MSPH, CCRC
CONTACT
202-476-3388
mewilliams@childrensnational.org
Sarah Mulkey, MD, PhD
CONTACT
sbmulkey@childrensnational.org

Principal Investigator

Sarah Mulkey, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

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