NCT05368038
ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Enrolling by Invitation
Not specifiedUp to 4ObservationalAlbert Einstein College of MedicineInvestigator-initiated
~100,000 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Confirmatory Testing
At a glance
Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the accuracy of the screening assays.
Measured over Through study completion up to 9 years.
+1 more outcome measured
Conditions
Where it's being run
9 sites across 1 statesNew York9
Study leadership
- Melissa Wasserstein, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
All newborn infants born at a ScreenPlus pilot hospital
Infants who are less than four weeks old, regardless of sex, gestational age, or health status.
Exclusion
A newborn screening sample is unavailable
Infants who are more than four weeks old
What this trial measures
- Evaluate the accuracy of the screening assays.Through study completion up to 9 years.
Accuracy of the screening assay will be defined in terms of positive predictive value (proportion of confirmed cases comparative to the total number of infants who screened positive).
- Define disease incidence in a large newborn population.Through study completion up to 9 years.
Disease incidence will be calculated as the proportion of infants with a disorder comparative to the total population of infants screened.