ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Public ClinicalTrials.gov record NCT05368038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ScreenPlus is a consented, multi-disorder pilot newborn screening program implemented in conjunction with the New York State Newborn Screening Program that provides families the option to have their newborn(s) screened for a panel of additional conditions. The study has three primary objectives: 1) define the analytic and clinical validity of multi-tiered screening assays for a flexible panel of disorders, 2) determine disease incidence in a large newborn population, and 3) assess the impact of early diagnosis on health outcomes. Over a nine-year period, ScreenPlus aims to screen 100,000 infants born in eight high birthrate hospitals in New York for a flexible panel of rare genetic disorders. This study will also evaluate the Ethical, Legal and Social issues pertaining to NBS for complex disorders, which will be done via online surveys that will be directed towards ScreenPlus parents who opt to participate and qualitative interviews with families of infants who are identified through ScreenPlus.
Study identification
- NCT ID
- NCT05368038
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 100,000 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- Up to 4 Weeks
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2021
- Primary completion
- Aug 30, 2029
- Completion
- Aug 30, 2029
- Last update posted
- Jul 27, 2026
2021 – 2029
United States locations
- U.S. sites
- 9
- U.S. states
- 1
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| NYU Langone Hospital - Brooklyn | Brooklyn | New York | 11220 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Langone Health - Tisch Hospital | New York | New York | 10016 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Mount Sinai Hospital | New York | New York | 10028 | — |
| Long Island Jewish Medical Center | Queens | New York | 11040 | — |
| Jack D. Weiler Hospital | The Bronx | New York | 10461 | — |
| ScreenPlus Coordinating Core, Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05368038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05368038 live on ClinicalTrials.gov.