BRIDGES-NBS

When does the study start?

• The study is in the planning stages and enrollment has not started. We expect it will likely start this winter.

How long is the study?

• It is a multi-year study that will take place over the next two to three years.

Who can join (enroll) in the study?

• Any baby born in Minnesota, under 32 days old, completing standard newborn screening.
• Joining the study is a choice. Parents of babies who are eligible to join will be offered the choice to consent and enroll their baby shortly after their baby is born.
• Signed consent from a baby’s parent (legal guardian) is required to join the research study. The parent signing must be able to read the consent form, which is available in English, Spanish, Arabic, Russian, Bengali, Somali and Chinese.

How will families be invited to join?

• Two hospital systems in Minnesota will have in-person staff inviting families in the nursery to join the study. Once contracts are in place, the names of the two hospital systems will be shared.
• If a family whose eligible baby is born in Minnesota wants to take part in the study, and their baby is not born in one of these hospital systems, they can still join and provide consent online. More information about this option will be shared once it is available.

What will be done in the study?

• Babies who are a part of the study will have newborn genomic screening done to look for genetic changes associated with genetic health conditions.
• The study will use the same dried spots already collected from standard newborn screening (NBS).
• After standard NBS is done at the MDH Public Health Laboratory, the dried blood spots from the babies enrolled in the study will be sent to GeneDx Laboratory where genomic sequencing will be done.

Is there a cost?

• There is no cost for sequencing done through the study. 
• Any costs related to follow-up care will follow typical health care billing (e.g. billing baby’s health insurance).

Will babies in Minnesota still get NBS done?

• Yes, this study does not change or replace standard NBS.

What does newborn genomic screening mean in the BRIDGES-NBS study?

• It means the screening is done using genome sequencing technology to read a baby’s genetic material (DNA) in 777 specific genes to look for changes that are known to cause certain health conditions. 
• It is not full genetic testing. It does not look at all of a baby’s genes or for every genetic condition. It also does not find or report every genetic change. If a baby has a genetic health concern, they should still see a genetics specialist and may need clinical genetic testing.
• To watch a video that helps explain genome sequencing and how it will be used, watch the Bridges-NBS video.

Can parents choose which conditions are looked for?

• No, parents cannot choose. Every baby in the study will have screening done to look for the same health conditions.

How were health conditions chosen?

Conditions had to meet the following:

• The condition can be found in a child's first year of life.
• It affects the child’s health or development.
• There is an approved treatment or monitoring plan that is expected to improve the child’s health and development that can be started before they turn 1 year old.
• The screening is good at finding the condition if it is present.
• The condition can be confirmed in other ways (e.g. with blood tests, imaging, physical exam, etc.).

What health conditions were not chosen?

Conditions were not chosen if:

• The condition only appears when a person becomes an adult.
• The condition does not have a known treatment or monitoring plan that can start early in life.
• The condition is not caused by a genetic change.

How long will it take for BRIDGES-NBS results to come back?

• BRIDGES-NBS results may take up to two to three months and will come back separately from standard newborn screening results.

How will BRIDGES-NBS results be shared?

• Any normal (negative) results will be sent back to the birth facility or midwife that collected the newborn screen. 
• Any abnormal (positive) results will be called to the baby’s primary care provider or their support staff by genetic counselors with the Newborn Screening Program at MDH. Recommended next steps will be discussed. The follow-up process is currently being planned in Minnesota. Additional information will be shared once this is finalized.

Does having a normal BRIDGES-NBS result mean a baby does not have a genetic condition?

• No. A normal BRIDGES-NBS result lowers the chance baby has a health condition looked for, however, it does not rule it out completely. The study also does not look for all genetic conditions. 
• If a baby has a health concern, they should still be seen by their healthcare provider to determine if more testing is needed.

Will the study affect standard newborn screening results?

• No, standard newborn screening results will be reported during the typical timeframe (usually less than 1 week).
   

• Minnesota specific materials about BRIDGES-NBS are under development—please check back
• Sign up for the MDH email list (GovDelivery)

• Frequently Asked Questions (FAQ)
• Main study page
• Study page for families 
• Genome Resource Center
• Conditions included in BRIDGES list
• Speak with a BRIDGES-NBS medical Geneticists/Genetic Counselor

• Genetic Information Nondiscrimination Act (GINA):
  • National Society of Genetic Counselors: GINA Fact Sheet
  • National Human Genome Research Institute: GINA
• Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: 
  • U.S. Department of Health & Human Services: HIPAA