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NCT05368038

ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program

Enrolling by Invitation
Not specifiedUp to 4Observational
Albert Einstein College of Medicine
~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

Acid Sphingomyelinase Deficiency
Ceroid Lipofuscinosis, Neuronal, 2
Cerebrotendinous Xanthomatosis
Fabry Disease
GM1 Gangliosidosis
Gaucher Disease
Lysosomal Acid Lipase Deficiency
Metachromatic Leukodystrophy
Mucopolysaccharidosis II
Mucopolysaccharidosis III-B
Mucopolysaccharidosis IV A
Mucopolysaccharidosis VI
Mucopolysaccharidosis VII
Niemann-Pick Disease, Type C

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Cerebrotendinous XanthomatosisDeficiency, Acid SphingomyelinaseFabry DiseaseGaucher DiseaseGM1 GangliosidosisHunter SyndromeLysosomal acid lipase deficiencyMaroteaux-Lamy SyndromeMetachromatic LeukodystrophyMorquio SyndromeMucopolysaccharidosis Type IIIBNeuronal Ceroid Lipofuscinosis Type 2Niemann-Pick Disease, Type CRare DisorderSly Syndrome

NCT05368038

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Jack D. Weiler Hospital

    The Bronx, New Yorkno site contact published

  • Long Island Jewish Medical Center

    Queens, New Yorkno site contact published

  • Maimonides Medical Center

    Brooklyn, New Yorkno site contact published

  • Mount Sinai Hospital

    New York, New Yorkno site contact published

  • Mount Sinai West

    New York, New Yorkno site contact published

  • North Shore University Hospital

    Manhasset, New Yorkno site contact published

  • NYU Langone Health - Tisch Hospital

    New York, New Yorkno site contact published

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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.