Early Check is a research study that tests babies soon after birth for serious health conditions. Early Check screening tests are free, and no appointments are needed. It’s up to parents to decide whether or not to sign up their babies.

Early Check is for babies born in North Carolina and babies currently living in North Carolina or South Carolina. Babies must have received standard North Carolina newborn screening to participate in Early Check.

Early Check has a limited number or sign-ups each week, so not all babies will be able to enroll.

Standard newborn screening is a process that happens after a baby is born. Before you leave the hospital or birthing center, a doctor or nurse pricks your baby’s heel with a needle to collect a few drops of blood. Then they send the blood to the North Carolina State Laboratory of Public Health to test for over 60 health conditions.

Early Check is not the same as standard North Carolina newborn screening. This table shows the differences.

*For most conditions there are treatments that help. For some conditions, researchers are looking for better treatments.

While standard newborn screening is automatic for all babies in North Carolina, Early Check screening is a research study that you can choose for your baby. If you choose not to sign up your baby in Early Check, your baby will still have standard newborn screening just like other babies in North Carolina.

Read more about how Early Check works and North Carolina's standard newborn screening.

• Knowledge is power. Taking part in Early Check can help you know whether your baby has any of these health conditions and their risk for developing type 1 diabetes. Most babies get a normal result. But if your baby has a condition, the sooner you know, the better. For risk of type 1 diabetes, knowing what symptoms to watch for can help children get treatment sooner.
• The tests are free and painless. The Early Check tests don't require any extra blood to be drawn from your baby. We use the same blood that is already taken through a heel prick after birth, so no new appointment is needed. You can sign up for Early Check online without a doctor.
• You can make a difference. By taking part in Early Check, you’ll help us learn the best ways to find health conditions in babies early. This can improve the lives of babies everywhere.

No. There are no charges to you or your insurance plan for taking part in Early Check. The costs are covered by the study.

Costs covered by Early Check include:  

• Early Check screening tests,
• help in understanding what results mean,
• an additional test for any baby whose screening test is not normal to confirm the first test.

If the additional test confirms the health problem, Early Check will provide for free:

• genetic counseling and education about the health problem,
• testing for parents when indicated,
• an assessment of the baby’s development, and
• help finding doctors and support services.

Early Check will pay for some additional tests, and then may recommend that the baby’s doctor or specialist run other tests that are not covered by the study.

Early Check does not pay for other tests ordered by the baby’s doctor or specialists, office visits, treatments, and other long-term care needs for the baby.

• Early Check screening will not find all health conditions in all babies.
• If Early Check finds a potential health condition in a baby, follow-up testing is done to learn more.
• All babies are different. For babies with the health conditions screened through Early Check, the study team and doctors will not know exactly when their symptoms will start and how severe the symptoms will be.

Early Check will use your baby’s blood sample only if you agree. It is your choice. If you decide not to take part in Early Check, your baby will still have standard North Carolina newborn screening and follow up. Your baby’s doctor will still receive the results of standard newborn screening.

Currently, Early Check can enroll a limited number of babies each week. If enrollment is closed, there will be a message posted on the Early Check Portal. Until a baby is one month old, parents can return to the portal weekly to see if enrollment has been reopened.

The Early Check screening tests are done from a small amount of blood that is taken from a baby’s heel as part of standard newborn screening shortly after birth in the hospital or birthing center. We send that same blood sample to the Early Check laboratory, so no additional blood sample is required for the Early Check screening tests. Occasionally the sample leftover from newborn screening is too small for Early Check testing, and so the baby will be withdrawn from the research study.

Learn more about how Early Check works.

That’s it! There’s nothing else you need to do. The Early Check team has your information and will conduct the extra tests using the blood sample already collected from your baby after birth. After the tests, Early Check will contact you with the results. Most parents get their baby’s Early Check results before the baby is 3-4 months old. Most parents get reassuring screening results for their baby.

The North Carolina State Lab conducts tests on your baby’s blood sample as part of standard newborn screening.

With your permission, the Early Check team will then test the same blood sample. The remaining blood sample will be stored at the State Laboratory of Public Health for up to 5 years. If you have questions about the storage of your baby’s blood sample, call the North Carolina State Laboratory at 919-733-3937. 

GeneDx is our partner laboratory. We send babies' blood samples to GeneDx for DNA sequencing labeled only with a study identification number.

• Strong security tools: The Early Check team works hard to protect your information. We protect the privacy and security of parents’ and babies’ information by keeping it on private and highly secure network. It is never possible to guarantee that a system is completely secure, but we have many strong tools in place to protect your information.
• Certificates of Confidentiality: Early Check also has Certificates of Confidentiality, which means researchers cannot be forced to disclose information that may identify you, even by a court subpoena, unless you provide written consent.

• Personal information is removed from samples before sending them to partner laboratories for testing. Partner laboratories will not share these samples with anyone else.
• Samples sent to GeneDx will be destroyed at the end of the study.
• The original newborn dried blood spots (DBS) cards are stored at North Carolina Laboratory of Public Health. Early Check will get a portion of the sample. Early Check will send the sample to the partner laboratory who will process the sample and perform the DNA sequencing. It is expected that the sample will be used up. Any leftover sample will be destroyed at or before the end of the study.

• Parents’ and babies’ names and contact information are never sold to anyone. They are never given to anyone outside of the Early Check team unless you provide your permission to do so.
• Early Check may share information from the study with other researchers and partnering companies, but it will not include any personal information. This means it cannot be traced back to you or your baby. Sharing this information allows Early Check to help research all over the country.

Yes, you can change your mind and withdraw from Early Check at any time. But if your baby's Early Check screening test has already been done, we’ll still contact you if the screening test is not normal. If you would like to withdraw from Early Check, contact us immediately.

After you take part in Early Check, we will contact you to ask about your experience with Early Check screening. We might contact you to see if you’re interested in participating in future research studies, which are completely voluntary.

• Email is Early Check's best way to contact you about results.
• After the test results come back, we will email only as needed to stay in touch with you.
• Because we rely on email to reach you about results, the only way to "unsubscribe" to Early Check email is to withdraw from the study, but that means you may not get your baby's test results.
• If you decide to leave Early Check, you can withdraw after signing in.

• Screened by Early Check via CK-MM from October 2020 - June 2023
• Screening via DNA sequencing starts in late 2023

Approximately 90% of babies with Duchenne muscular dystrophy (DMD) can be identified by Early Check using DNA sequencing. It is considered by the Early Check team to be a condition with potential treatments (Group 2). Currently, there is no cure for muscular dystrophy, but there are treatments and early intervention services that can help.

Screened by Early Check from 10/15/2018 - 12/10/2021.

The Early Check panel stopped screening for Spinal Muscular Atrophy (SMA) on April 1, 2021. Soon after, the North Carolina standard newborn screening program started screening for SMA. 

• Screened by Early Check from 10/15/2018 - 3/31/2021
• Screened by North Carolina newborn screening beginning in early 2021
• Screened by Early Check DNA sequencing beginning in late 2023

If you have questions about state newborn screening for SMA, please contact the NC State Laboratory of Public Health at (919) 733-3937. If you have concerns about your baby's development, please contact your healthcare provider.