Early Check is not yet available and program planning is still under development. Currently, the Early Check model focuses on five steps:
Step 1. Reaching out
New and expecting parents in North Carolina will be invited to join Early Check, a research study that screens newborns for rare health problems. We will give parents information to help them decide whether signing up for Early Check is right for them and their family.
Step 2. Signing up
Parents will choose whether or not to give permission to screen for spinal muscular atrophy and fragile X syndrome by signing up to participate in Early Check up to 4 weeks after their baby is born.
Step 3. Screening
The North Carolina State Laboratory of Public Health will run the tests for additional conditions offered by Early Check. The lab will use the same blood samples for these tests that were already collected for regular newborn screening. The lab will only perform these additional tests if parents give their permission by signing up for Early Check.
Step 4. Reporting results
Almost all of the babies tested for spinal muscular atrophy and fragile X syndrome in Early Check will not have those conditions. If the result is normal, parents will receive a text or email telling them that the Early Check test results are ready. Parents will be able to view the test results on the secure Early Check website. However, if the result is not normal, a member of the Early Check team will call the parent to schedule additional testing to confirm the findings.
Step 5. Following up
The baby will get an exam and the family will get information and genetic counseling. Early Check will help find doctors to care for the baby. We will invite parents to enroll in a research registry and give them information about ongoing medical research studies.
Our approach to working with families will be grounded in overarching principles of showing respect for parents and babies, earning trust, complying with regulations, and being sustainable. We believe it is very important to help families make choices that are right for them at every stage of the program.