If pregnant women or new moms seek your guidance about the GUARDIAN Study, please refer them to our website to learn more about the study.
For Healthcare Providers
What Else You Need to Know
The testing is free and does not require an extra blood draw.
We will offer the testing at no cost to families, and no insurance is needed. The testing is done using the dried blood spot from standard newborn screening so no additional blood is drawn and there will be no harm or pain to the newborn.
We will screen for a panel of conditions.
We will test newborns for a panel of conditions not included in standard newborn screening. There are two groups of condition. All babies participating in the study will be screened for conditions in Group 1. For Group 2, parents can choose whether or not to have their baby screened for them.
All women who deliver at a NewYork-Presbyterian hospital will be invited to the study. Women can also sign up on the website before they deliver.
Women who deliver at a NewYork-Presbyterian hospitals will be invited to the study. Women who deliver a healthy baby after 33 weeks gestation and speak English or Spanish will be invited to the study. Women can sign up for the study prenatally if they are more than 12 weeks pregnant and plan to deliver at one of the study locations. The consent for the study will be completed after the baby is born.
The consent process occurs entirely through our secure online permissions portal and is completely voluntary on the part of the parents.
New moms may get an email about GUARDIAN.
There are several ways that women and new moms may learn about the GUARDIAN study. They may see flyers for it in their OB/GYN’s office or other hospital locations. They may be invited by an in person study recruiter shortly after they deliver their baby or they may receive an email inviting them to the study shortly after delivery of their baby.
The Invitation to the GUARDIAN Study that new moms will receive.
The GUARDIAN study is not the same as the standard New York State Newborn Screening Program.
Although the study uses the same blood sample taken for standard newborn screening, it is different in a few key ways. The GUARDIAN study is voluntary and done only if parents explicitly opt in to the testing. The test results are reported to families and to the child’s pediatrician. They are also reported to the New York State Department of Health Newborn Screening Program.
Parents and providers will be contacted with the test results about 3-6 weeks after the baby is enrolled in the study.
Testing will be completed after the standard NBS panel is completed and results are typically ready about 3-6 weeks after the baby is enrolled.
Most newborns will screen negative. We will contact parents with negative results by phone or email.
Positive results will be communicated to parents and pediatricians by a genetic counselor and or geneticist and follow up genetic counseling will be completed as part of the study. In some cases, there is additional testing to confirm the diagnosis. The genetic counselor and geneticist will give families information, counseling, and recommendations for medical care. Also, the genetic counselor will connect families with specialists, and give them information about research studies looking for possible new treatments.
The genetic counselor will report the test results to the pediatrician if we cannot reach the family directly.
In these scenarios, the genetic counselor will call the pediatrician and let them know about the positive screen or confirmed diagnosis. We will provide information about the condition along with the lab result following this call. The genetic counselor will encourage the family to inform their baby’s pediatrician and offer to contact them directly on their behalf if they prefer.
The study is a collaboration between nonprofit, academic, and government organizations.
GUARDIAN is led by a collaborative Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, and the New York State Department of Health.
You can help by referring pregnant women to the GUARDIAN study website.
If a pregnant woman or new mom asks you for guidance about participating in the study, please direct her to our homepage. Our website has information for families in both English and Spanish. Families can contact our team at 718-514-4947 or [email protected].
You can download an GUARDIAN study flyer to share with patients and families.
Help us spread the word about the GUARDIAN study! Download and share this 1-page flyer (English or Spanish) in your office or on your website.
Genomic sequencing data are stored in a secure and confidential manner.
Genomic sequencing data generated by this study along with basic demographic information will be stored in an identifiable manner by Columbia University for the duration of the study. After completion of the study, any identifiable markers will be removed, such as child’s name or DOB, and Columbia University will store the de-identified data indefinitely. No additional analysis beyond what is completed as part of the study will be done on the sample unless requested by the family or treating pediatrician or if the family has consented to a new research study.
Blood spots are stored by the NY State Lab. Parent information is kept secure and confidential.
Patient information is shared only with the GUARDIAN study researchers and is regulated by HIPAA.
Families and physicians can request a re-analysis of genomic sequencing data if the child has symptoms of a genetic condition not included on the screen.
Families and physicians will have the option to re-contact the study if their child becomes symptomatic of a possible genetic condition that was not included on the screen. Please contact us at 718-514-4947 or [email protected] to learn more about requesting data for a re-analysis that the family will have to pay for outside of the study.
Genomic sequencing data will be shared anonymously with other researchers.
The genomic sequencing data will also be anonymized and stored on a secure server and pooled genetic information will be available on an online browser to make the data available for the wider scientific community. This database will be available to the entire research community to advance all genetic research.
We can answer your questions about the study.
Find answers to commonly asked questions here. You can also contact us at 718-514-4947 or [email protected].