Important Things to Consider

Some parents want to know right away, before most symptoms start, if their baby has a serious health condition. Knowing early may allow earlier and better treatment.
Other parents may prefer to wait and only test if their baby has symptoms of a health condition.

Early Check is a research study.

If you sign up your baby for Early Check, you are joining a research study. The goal of Early Check is to learn about acceptable ways to find serious health conditions in babies so they can get help sooner.
Because Early Check is a research study, the screening results are not automatically placed in your child’s medical record.
You can withdraw at any time. If you’d like to withdraw, contact us at any time. If the baby’s Early Check screening test has already been done, we’ll still contact you if the screening test is not normal.
Early Check has the right to withdraw participants if needed before the screening tests have been run. If this happens, parents will be notified by email.

Early Check testing is free.

Early Check is free. Early Check will not charge you or your insurance plan for Early Check screening.
If your baby gets a result from a screening test that is not normal, Early Check will confirm the result for free.

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:

Costs not covered by Early Check include:

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 doctor and specialist office visits or treatments for the baby.

Screening tests are not perfect.

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 is not a substitute for standard newborn screening.

Early Check is not the same as standard North Carolina newborn screening. Learn more about North Carolina newborn screening below.

North Carolina standard newborn screening is a free program.
In the hospital or birthing center, a nurse or other healthcare professional will prick the baby’s heel with a small needle to collect a few drops of blood. The hospital sends the drops of blood to the North Carolina State Laboratory of Public Health (NCSLPH) in Raleigh for testing. Basic information about the baby, such as date of birth, sex, and birth weight, is also sent.
This is the same blood sample that will be used for Early Check screening tests. Early Check also uses this basic information about the baby to make sure the screening result is as accurate as possible.
You can learn more about standard newborn screening in North Carolina here.

If you choose not to join Early Check, your baby will still have standard North Carolina newborn screening and follow up.
It would be very rare, but it is possible that a baby could have a health problem found on standard newborn screening and also have an Early Check screening test that was not normal. If this ever happens, the Early Check team will tell the newborn screening professionals and doctors caring for the baby to make sure the baby has coordinated care.
Early Check uses DNA sequencing to test for many of the conditions that are also tested by standard newborn screening. Because Early Check and standard newborn screening test for these conditions in different ways, it’s possible that the results will not match. The Early Check team may ask you to share your child's standard newborn screening results for these conditions with the study team. Finding and explaining those mismatches is one of the research goals. The Early Check team will explain any mismatches to the family.

This table shows the differences between standard North Carolina newborn screening and Early Check.

	Early Check	Standard Newborn Screening
Parents must give permission for their babies to be screened	Yes	No
There are treatments for babies with health problems that can greatly improve their symptoms	Yes, for some but not all*	Yes
Type of program	Research	Public Health

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

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