About this trial
The goal of this study is to learn how genomic sequencing technology can be used to effectively expand the conditions screened on newborn screening. Newborn screening ensures equity and allows all babies to have the same chance at the healthiest life. Families will be invited to have their newborn baby screened for additional conditions beyond what all babies are screened for as part of the newborn screening public health program. Families can choose to be part of the study or choose not to be part of the study and just have the routine newborn screening test. Families will also be able to choose to learn about their baby's risk for conditions that have effective treatments available but are not on the routine newborn screening panel or also learn about conditions for which there is not currently FDA approved medications but for which medications are under development or for which early intervention services or treatment of seizures may improve the child's outcome. Families will be invited to the study shortly after the baby is born and will learn the decision not to participate, and we will interview a subset of parents who agree to be interviewed. Newborns who screen positive will be referred to appropriate providers for care and will be followed through review of electronic medical records and parental follow up via phone, text, postal mail or email.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Newborns admitted to the well-baby nurseries from the recruiting hospitals
Newborns born after 33 weeks of gestation
Newborns whose parents are English, Mandarin, or Spanish speaking
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Genome sequencing-based newborn screening
Other interventionDried blood spots collected at birth for routine newborn screening will be used for genome sequencing based screening of a defined set of conditions.
Treatment groups
Trial outcomes
Primary outcomes
Enrollment Rate (percentage)
Enrollment rate will be defined as: number of enrolled newborns / number of newborns approached by the research assistant.
Successful Sequencing Rate (percentage)
Successful sequencing rate will be defined as: number of successful sequencing / number of enrolled newborns.
Screen Positive Rate (percentage)
Screen positive rate will be defined as: number of newborns with a positive screening / number of successful sequencing.
True Positive Rate (percentage)
True positive rate will be defined as: number of confirmed diagnosis / number of screen positive.
Secondary outcomes
Score on Decision Regret Scale
The Decision Regret Scale measures distress or remorse after a health care decision. This 5-items scale ranges from 0 (no regrets - best outcome) to 100 (highest regret - worst outcome). Scores above 1 and below 25 are considered as an indication of mild regret. Scores above 25 are considered as an indication of moderate to severe regret.
Sponsors and contacts
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Columbia University
Lead sponsor
Illumina, Inc.
Collaborator
GeneDx
Collaborator
New York State Department of Health
Collaborator