The Wisconsin SHINE Project
The Wisconsin SHINE Project was created to evaluate the effectiveness of and the costs associated with pulse oximetry screening for critical congenital heart disease (CCHD) in newborns. The SHINE project is a collaborative effort of the University of Wisconsin, Medical College of Wisconsin, Wisconsin Department of Health Services, and Wisconsin State Laboratory of Hygiene and is funded by a grant from the US Health Resources and Services Administration (HRSA), a branch of the US Department of Health and Human Services. The SHINE project hopes to collect information on all Wisconsin’s births, including hospital, birthing center, and home deliveries.
What Does the SHINE Project hope to accomplish?
A growing body of literature shows that pulse oximetry screening for CCHD is an effect tool for detecting CCHD that might otherwise have been missed prior to hospital discharge. The primary purpose of the SHINE Project is to see if pulse oximetry is an effective screening tool for CCHD across the wide range of birth settings in the State of Wisconsin. The SHINE project will also evaluate the costs associated with pulse oximetry screening and the response to failed screenings.
What counts as Critical Congenital Heart Disease CCHD?
Although there is no perfect definition, the SHINE project defines CCHD as one of twelve diagnoses. HRSA and the Centers for Disease Control have identified Hypoplastic Left Heart Syndrome, Pulmonary Atresia, Tetralogy of Fallot, Total Anomalous Pulmonary Venous Return, Transposition of the Great Arteries, Tricuspid Atresia, Truncus Arteriousus, Coarctation of the Aorta, Double Outlet Right Ventricle, Ebstein’s Anomaly, Interrupted Aortic Arch, and Single Ventricle as targets for pulse oximetry screening. There are somewhere in the neighborhood of 150 babies born in Wisconsin with one of these diagnoses each year.
How do you do the screening?
We recommend using the screening protocol endorsed by the US Secretary of Health and Human Services and the American Academy of Pediatrics. This approach uses a “Two Sites, Three Strikes” approach. Pulse oximetry measurements are made in the right hand and one foot. A baby can have as many as three chances to pass the screening unless one of the oxygen saturations is <90%. More information about the screening process and how to respond to a failed screening is available at the SHINE website. www.wisconsinshine.org
What information is being collected for the SHINE Project and when?
Participating hospitals, birth centers, and midwives will provide information relating to the logistics and costs of performing pulse oximetry screening and responding to failed oximetry screenings. Pulse oximetry has its lowest false positive rate if performed 24 hours after birth or later. We recommend linking pulse oximetry screening with collection of the newborn screening blood specimen as this appears to be the most efficient way to gather and report the results of the pulse oximetry screening. The pulse oximetry result will be recorded on the newborn screening blood collection card by checking the appropriate box (PASS, FAIL, or NOT TESTED).
Additional information will be requested on babies who were born at a birthing center or at home, failed the pulse oximetry screening, were known to have CCHD prior to the oximetry screening, or were found to have had CCHD after being discharged from newborn care.
Which babies should be screened?
Our goal is that every baby born in Wisconsin should have pulse oximetry screening performed. To be certain that the pulse oximetry screening is as sensitive as we think it should be we do want to perform pulse oximetry screening on babies who are already known to have CCHD. If a baby is on supplemental oxygen because of lung disease, the pulse oximetry screening will be very difficult to interpret properly. When a baby is on oxygen at the time their newborn screening blood specimen is collected, pulse oximetry screening should be deferred until they no longer need supplemental oxygen or are being discharged home on supplemental oxygen.
Who will collect the information on babies?
Hospital Caregivers: For the vast majority of babies, the information reported to the SHINE project will be limited to checking one of three boxes on the newborn screening blood collection card. However, if a baby fails the pulse oximetry screening or is known to have CCHD, we ask that one of the baby’s caregivers contact the SHINE on-‐call personnel to let us know a little more about the baby and the details of the screening.
Midwives: In addition to checking one of the three boxes on the newborn screening blood collection card, participating midwives will complete a more detailed report on the baby and the screening process. The SHINE Project is placing a special focus on out of hospital births as the rate of missed congenital heart disease appears to be higher in this population.
Pediatric Subspecialists: SHINE study personnel in Madison and Milwaukee will be on the lookout for babies with one of the 12 CCHD diagnoses who are admitted to either the American Family Children’s Hospital or the Children’s Hospital of Wisconsin. We ask that anyone who makes a new diagnosis of one of the 12 types of CCHD in a Wisconsin-‐born baby will contact us if that baby is not sent to either the American Family Children’s Hospital or the Children’s Hospital of Wisconsin for further care.