Frequently Asked Questions

Below are some common questions about Lyme disease and our child neurodevelopment study.

For information about our other work, or if you have a question not listed here, please feel free to contact us.

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Lyme Disease (General)

Lyme Disease (General)

What is Lyme disease?

Lyme disease is an infection spread by some ticks. It can cause symptoms like an erythema migrans rash (also known as a “bullseye” rash), fever, body pains, or problems with thinking. It is the most common tick-borne disease in the United States.

What is post-treatment Lyme disease syndrome?

Most of the time, Lyme disease symptoms go away with treatment. However, some people still have symptoms that do not get better after their initial treatment. This is called Post-Treatment Lyme Disease Syndrome, or PTLDS. The cause of PTLDS is not currently known.

I found a tick on me! What do I do?

First, try to stay calm! If the tick is attached to your skin, you will want to remove it as quickly as possible, monitor your symptoms, and contact your health care provider.

Safely remove the tick. Grab the tick close to your skin with a pair of tweezers and pull it straight upward. You can dispose of the tick by flushing it down the toilet. Some people choose to kill the tick by putting it in alcohol and then placing it in a small plastic bag or container to show their doctor. You may want to take a photo of the tick to show your doctor if you decide to dispose of it. After removing it, wash the spot where it was attached with soap and water.
Monitor your symptoms. Note any unusual symptoms you have over the next couple weeks. Contact your provider if you develop a “bullseye” shaped rash, fever or flu-like symptoms, joint pain, headaches or signs of infection. Your provider can talk you through options for treatment that are safe for you and your baby.
Contact your health care provider. Let them know you were bitten by a tick. If you have a photo or if you kept the tick, show them what it looks like. They may help you identify whether it is the type of tick that carries Lyme disease (a deer tick), and together you may decide whether to take preventative antibiotics.

Will Lyme disease affect an unborn baby? What if I get diagnosed while I am pregnant or still have symptoms during pregnancy?

These are excellent questions. At the time, effects of acute Lyme disease or PTLDS on pregnancy and child outcomes are not fully understood. There are some studies (like this recent retrospective cohort study and this systematic review) that look at outcomes during pregnancy and the neonatal period, but there is not enough evidence to know if Lyme disease affects children long-term. We also don’t know if (or how) the bacteria that causes Lyme disease crosses or affects the placenta. We’re trying to learn, though! Learn about our study below.

About the Study

What is the purpose of this study?

This is a pilot study to assess the feasibility of following the neurodevelopment of babies who were exposed to Lyme disease in utero through 18 months of age. The purpose of this research is to understand how in utero exposure to Lyme disease may impact brain development during infancy and early childhood.

Who is leading this study?

This study is led by Dr. Sarah Mulkey and Dr. Roberta DeBiasi, co-directors of the Congenital Infection Program at Children’s National Hospital in Washington, DC. The Congenital Infection Program specializes in evaluating and researching outcomes of children with in utero exposure to infections such as Lyme disease. The lead research coordinator for this study is Meagan Williams. You can learn more about the study team here.

Who is funding this study?

We are very grateful to receive grant funding for this pilot study from the Lyme Clinical Trials Network supported by the Steven and Alexandra Cohen Foundation.

Have similar studies on Lyme disease been done before?

There have been other studies which have looked at pregnancy outcomes following Lyme disease, but this is the first study to follow infants systematically and longitudinally through childhood.

Are you studying the impact of other tick-borne diseases or co-infections?

We understand the complexity of navigating a Lyme disease diagnosis. At this time, we are recruiting people who are confirmed to have been infected with Borrelia burgdorferi. It is possible that our participants may also have other co-infections. Our long-term follow-up will provide you with the opportunity to share about other illnesses and experiences that are part of your medical history in addition to B. burgdorferi.

Joining the Study

Am I eligible to join this study?

We are enrolling patients who are currently pregnant and have a recent history of Lyme disease. You may be in any trimester of pregnancy to enroll.

You may be eligible for the study if you are pregnant and you:

were bitten by a tick and clinically diagnosed (using CDC criteria for clinical/laboratory diagnosis) with Lyme disease during any trimester of your current pregnancy, OR
completed treatment for clinically diagnosed Lyme disease (using CDC criteria for clinical/laboratory diagnosis) between 6 months and 5 years ago AND currently have active symptoms attributed to clinically diagnosed Post-Treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme.

What labs are required to show that I was clinically diagnosed with Lyme/PTLDS?

For this pilot study, we will be enrolling patients who meet the strictest definition of having a Lyme disease diagnosis per CDC guidelines, including a clinician-diagnosed erythema migrans (EM) rash and/or FDA-approved two-tiered testing.

We are aware that obtaining a clinical Lyme diagnosis is a multi-step process and that FDA-approved diagnostic tests may not capture every patient with Lyme. For this pilot study, we cannot include labs that have not received FDA approval for eligibility.

The primary aim of this pilot study is to assess feasibility of enrolling and following pregnant participants with Lyme disease or PTLDS. We hope that the results of our pilot study demonstrate that this is feasible, and that we can then obtain additional funding to include other subgroups of people that have positive testing by other modalities that are not currently FDA-approved.

My child is X years old and I think they have been affected by Lyme disease. Can I enroll us in the study?

Thank you so much for your interest in participating. For this pilot study, we are only recruiting participants who are currently pregnant. This is so we can collect important information such as fetal development and any abnormalities in the placenta. Future work after this pilot study may include other groups of participants, such as those with older children. If you are interested in being contacted for future studies, please let us know.

I was diagnosed with Lyme disease X years ago and was treated. I am now pregnant and am not experiencing any symptoms. Can I enroll in the study?

For this pilot study, we will not be enrolling patients who were treated for Lyme disease before pregnancy and who no longer have symptoms. Participants in this study must either: (1) have been diagnosed with Lyme disease during their current pregnancy, OR (2) have been diagnosed with Lyme disease between 6 months and 5 years ago AND currently have active symptoms clinically attributed to post-treatment Lyme disease syndrome (PTLDS) or Chronic Lyme.

I have PTLDS/Chronic Lyme and am pregnant. Can I still participate if I’m currently undergoing treatment?

Yes, you may participate as long as you fulfill the other eligibility requirements. Receiving treatment for Lyme or PTLDS is not a reason for excluding participants from this study.

I live in Canada. Can I still participate?

Yes! This study is open to participants in the United States and Canada.

If I participate, how long will I be in the study?

If you decide to participate, you will join the study when you are pregnant. You may join the study at any trimester of pregnancy. You will be in the study until your child is 18 months old. You are free to leave the study at any time.

How many other people are in this study?

We are hoping to recruit 40 pregnant people and their infants for this study. We hope that future studies will include additional cohorts and a larger sample size.

Study Participation

What will happen in this study?

In this study, we will study your child’s development until they reach
18 months of age. At each study visit, we will monitor your Lyme/PTLDS experience and collect information from you using online surveys.

During Pregnancy: We will do blood tests, perform a fetal MRI and ultrasound during your 2^nd or 3^rd trimester, and collect information from you about your Lyme/PTLDS history. You may also choose to participate in a qualitative interview with our research team to help us learn more about your feelings and experiences during pregnancy.
After Delivery: When your baby is born, we will collect information about your labor/delivery and your baby. We will also analyze your placenta for any abnormalities.
During Infancy: Your baby will have an in-person visit to receive a brain MRI and ultrasound when they are between 2-6 weeks old. We will also analyze your baby’s blood. You will complete standardized assessments and will meet with our neurologist using telehealth multiple times throughout the study to review your baby’s health and development. One additional in-person visit with the study neurologist may occur when your child is 1 year old.

You will be compensated for your time at each in-person and online study visit.

Do I have to travel to Washington, DC?

It is important that you attend as many in-person study visits as possible so we can learn as much as we can about you and your baby. In-person study visits will occur at Children’s National Hospital in Washington, DC.
We hope that you can attend in-person study visits during your 2^nd or 3^rd trimester, when your baby is 2-6 weeks old, and when your baby is 12 months old. This is so we can complete the imaging (MRI and ultrasound) and neurological examination parts of the study. These parts of the study are very important in helping us learn about your baby’s development.

Reimbursement for travel is available for each in-person study visit; please email us for details.

If you are not able to come to one or more of these in-person visits, you are still eligible to participate in this study. We will modify the study visit so you can join online via Zoom telehealth.

Will you tell me how my child is doing after you evaluate them?

Of course! After each study visit you will receive a personal phone call from our study doctor to go over the results of your baby’s assessment. You will also receive a written feedback form for your records.

Will you talk to my other doctors or health care providers? Will they know I am part of this study?

As part of this study, we will ask that you and/or your doctors share some medical information with us so we can learn about your Lyme diagnosis and history. We will also collect records from your birth hospital after your baby is born. We will not contact your doctors or health care providers, or collect medical information about you or your baby, without explicit permission from you. If you’d like, you are welcome to tell your and your child’s providers that you are participating in this study to follow your child’s neurodevelopment.

What kinds of surveys will I complete? What if I want to share more about my experience?

You will be invited to complete surveys about your and your baby’s medical history and nutrition, your pregnancy history, demographic information, and more. Once your baby is 2 months old, you will also complete a neurodevelopmental screening survey at each study visit.

Study participants are invited to participate in an optional interview with a member of our research team. This semi-structured interview will help us learn more about your experiences navigating Lyme disease or PTLDS/Chronic Lyme during pregnancy.

Will I be paid for participating in this study?

Yes. When you enroll in the study, you will receive a Clincard, which works like a debit card. You will receive compensation for each online and in-person study visit. The payment will be automatically loaded to your card after you complete each study visit.

Study Procedures

What areas of development will you be looking at in this study?

We will be looking at a wide range of neurodevelopmental outcomes among infants in our study beginning at 2 months of age through 18 months of age. For example, we will assess age-appropriate measures of communication, movement (fine and gross motor), social cognition, and problem solving skills.
We do not have a specific evaluation plan for conditions that tend to show up later in childhood, like autism. However, we hope that with additional funding we may be able to follow these children longer than 18 months, such as through toddlerhood and early childhood. In this case, we will assess additional areas of development appropriate for older ages.

What will the MRI be looking for?

Both the fetal MRI and the postnatal MRI will be done to find any structural abnormalities to the developing brain. For example, we will measure brain volume, and do quantitative analysis to look at gray and white matter, to determine if there are any differences in the way the brain is developing.

Can I get the MRI and/or ultrasound imaging for this study be done somewhere else?

If another institution performs clinical imaging (for example, if your obstetrician performs a fetal ultrasound) you may feel free to share those records with us. However, the in-person portion of this study including all MRI and ultrasound imaging needs to be completed at Children’s National Hospital in Washington, DC in order for the study to pay for it. You will not be compensated for imaging that occurs outside of this study at Children’s National.

Will any special studies be done on the placentas?

We will do special testing on the placenta to look for the Borrelia burgdorferi spirochete and any other evidence of placental tissue abnormality or signs of inflammation.

Are you collecting cord blood for this study?

No, we are not collecting cord blood. We will do bloodwork on the pregnant participant and the newborn.

Other/Miscellaneous

What will happen if you find that a baby or placenta has been infected with Lyme disease?

While our study is aimed toward infant neurodevelopmental assessment and not treatment of Lyme, it is important to us that our participants get the best care possible in alignment with current recommendations and best practices for treatment. If we feel a participant would benefit from clinical evaluation or follow-up beyond the scope of our study, we may make a referral to a specialized doctor in the participant’s region. This may include the Congenital Infection Program at Children’s National Hospital for any infected babies or children in the Washington, DC area.

What will happen in the event of a miscarriage or stillbirth?

We certainly hope that none of our participants have the experience of a miscarriage or stillbirth. If this does occur, we will work with the obstetrician, maternal-fetal medicine doctor, and/or birth hospital to obtain fetal tissues and the placenta for additional Lyme-related testing. Our consent form goes into further detail about this process.

Who is funding this study and how are they involved?

We are very grateful to receive grant funding for this pilot study from the Lyme Clinical Trials Network supported by the Steven and Alexandra Cohen Foundation. We meet with members of the Lyme Clinical Trials Network regularly for project guidance and feedback.

FAQs for Providers

I have a patient who I think might be eligible. Can I share their contact information with you?

With your patient’s permission, you may share their contact information with our study team by emailing their information to mewilliams@childrensnational.org. If you would like to refer a patient to our study, you may also share our website and/or study flyer with them or invite them to fill out the eligibility screener at www.redcap.link/CNHLYME.

I’m interested in collaborating with you on this study. What can I do?

Thank you very much for your interest! We are very grateful to our collaborators for making this study possible. Here are some ways you can help us:

Please spread the word about our study! Feel free to post our flyer in your office or waiting room, on your website, or other places where your patients and/or colleagues may find it. You may use our Social Media Templates in the Recruitment Toolkit for sample language for posting on social media, blogs or newsletters, or your website. If you need access to this document, please contact us.
If you know someone personally who may be interested in participating, please share information about our study and invite them to complete the eligibility screener at www.redcap.link/CNHLYME.
You may also join our email list to receive our periodic newsletter with updates about our Lyme study. If you’d like to join this list, please sign up here.
We hope that after this pilot study, we can obtain additional funding to conduct a larger multi-center study. If you are interested in exploring the possibility of joining our multi-center study as a study site, please contact us.

If you have other ideas on how we can collaborate, please let us know. We look forward to hearing from you!