Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

NCT06026969 | Recruiting

• 1 other identifier: 00000425
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  7/1/2023 - 6/30/2025

Secondary Outcomes (10)

• Warner Initial Developmental Evaluation (WIDEA)

  Child ages: 2 months, 6 months, 12 months, 18 months

• Ages and Stages Questionnaire (ASQ)

  Child ages: 2 months, 6 months, 12 months, 18 months

• Alberta Infant Motor Scale (AIMS)

  Child ages: 2 months, 6 months, 12 months, 18 months

• Infant height

  All study visits between birth - 18 months of age

• Infant weight

  All study visits between birth - 18 months of age

Study Arms (2)

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.

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.

Other: Neurodevelopmental assessments and follow-up

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.

Lyme disease; Post-treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Intellectually unable to comprehend study procedures
• Health issues or metallic implant that precludes undergoing MRI

Sponsors & Collaborators

• Children's National Research Institute: lead
• Clinical Trials Network for Lyme and Other Tick-Borne Diseases: collaborator
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Related Links

• Participant enrollment screener

MeSH Terms

Conditions

Lyme Disease; Post-Lyme Disease Syndrome; Tick-Borne Diseases; Pregnancy Complications

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sarah Mulkey, MD, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meagan Williams, MSPH, CCRC

CONTACT

202-476-3388; mewilliams@childrensnational.org

Sarah Mulkey, MD, PhD

CONTACT

sbmulkey@childrensnational.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 7, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)