Project FIND-OUT is open to infants in the United States between the ages of 3-12 months displaying two of the following symptoms.
- Feeding or gastrointestinal issues
- Issues with movement/abnormal movements
- Neonatal intensive care (NICU) admission
- Developmental delay
- Other (congenital malformations, atypical growth or specialist referral)
- Unprovoked seizures
- Tone
Babies with feeding issues, problems with movement or muscle tone, or who have missed developmental milestones may be at risk of having a genetic neurodevelopmental disorder. These disorders can be diagnosed by genetic testing.
Project FIND-OUT provides a free neurological assessment, whole genome sequencing (a type of genetic testing) for your baby, and genetic counseling for your family. Your doctor will receive the results from whole genome sequencing along with recommendations on next steps including potential referrals to specialists and additional testing. All Project FIND-OUT services are free and available via phone and online – you will not need to travel.
You will need to:
- Complete the enrollment form online or fill out the paper form and email to us at projectfindout@combinedbrain.
org. - Participate in a one-hour online meeting (via FaceTime, Zoom, or other online platform) where you will learn about the study, complete a consent form, register with our web platform, and complete some forms about your child.
- Participate in a 15-minute online virtual assessment (online via FaceTime, Zoom, or other online platform). Your baby will need to be present during this assessment.
- Receive and return the genetic test kit, which will require you to swab the inside of your baby’s cheek and then return the test kit to our partner laboratory.
- Participate in a 30-minute genetic counseling session over the phone once the results are available.
- Complete online forms about your child about 12 weeks after the genetic counseling session.
- Have a phone conversation with the Project FIND-OUT team to provide your feedback (optional).
During the online meeting, it will be helpful for you to have some information about your baby:
- Number of weeks the mother was pregnant when the baby was born
- Baby’s weight at birth
- Baby’s length at birth
- Baby’s head circumference at birth
- Baby’s weight at most recent doctor’s visit (and date of that visit)
- Baby’s length at most recent doctor’s visit
- Baby’s head circumference at most recent doctor’s visit
The genetic test requires you to swab the inside of your baby’s mouth. While the swab will work for almost all babies, in rare circumstances it is possible that the swab may not collect enough genetic material.If this happens you will be given the option of having your baby’s blood drawn. The project can provide a phlebotomist to draw your baby’s blood at your home or another location that is convenient for you.
No, all Project FIND-OUT services are free to families.
However, as a result of the assessment and genetic test, the Project FIND-OUT team may recommend that your baby see a specialist or get additional testing done. These services are not provided by Project FIND-OUT and you may choose to have them billed to your insurance.
The results of the genetic test should be available within 6 weeks from when you return the kit to the laboratory partner.
Some of the risks include:
- Some genetic testing may return a “non-diagnostic” result which may require you to collect another sample or collect a different type of sample (e.g., via blood draw) in order to receive results.
- Your child may or may not get a diagnosis from WGS. Not every child who meets the Project FIND-OUT criteria will have a genetic cause and not every genetic cause will be identified in testing.
- If your child receives a genetic diagnosis, there may or may not be a treatment available for the genetic disease.
Please contact us at projectfindout@combinedbrain.org
The whole genome sequencing is being provided for free as part of a research study. Many insurance companies do not currently cover genetic testing or require families to pay high out-of-pocket costs. Some insurance companies have stated that more data is needed to demonstrate that whole genome sequencing is cost effective and improves outcomes for patients. We have designed Project FIND-OUT to collect the data needed to demonstrate that whole genome sequencing should be paid for by insurance. Because we are collecting data, your participation in Project FIND-OUT will require more of your time. We will need to collect information about you and your baby at the time you enroll and then again 12 weeks after you get your genetic test results back.
Your data will be used to provide services to you and your family including whole genome sequencing and genetic counseling. We will also analyze your data, along with the data of others, to measure our research objectives. During the enrollment process, you will be given the opportunity to review how your data will be used and answer any questions you might have. Project FIND-OUT is being conducted by the Consortium for Outcome Measures and Biomarkers for Neurodevelopmental Disorders (COMBINEDBrain), a non-profit organization devoted to finding treatments for people with rare genetic neurodevelopmental disorders. To learn more about their mission and programs, please visit www.combinedbrain.org. Your data will be stored in a secure HIPAA-compliant database managed by COMBINEDBrain.
