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New york program offers extra screening for 100,000 newborns

NCT ID NCT05368038

Diagnosis Sponsor: Albert Einstein College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

ScreenPlus is a large pilot program that offers families the option to have their newborn screened for a panel of rare genetic disorders, in addition to standard newborn screening. The study aims to screen 100,000 infants born at eight hospitals in New York. Researchers will evaluate the accuracy of the screening tests and study the impact of early diagnosis on health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to earlier diagnosis and better health outcomes for babies with rare genetic disorders.
What could go wrong
This is an observational screening study, not a treatment trial. It will not directly cure or treat any condition. The impact depends on follow-up care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Newborns born at a ScreenPlus pilot hospital who are less than four weeks old.

Ages

Up to 4 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * A newborn screening sample is unavailable * Infants who are more than four weeks old

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Conditions

The condition(s) this trial relates to.

acid sphingomyelinase deficiency cerebrotendinous xanthomatosis Ceroid Lipofuscinosis, Neuronal, 2 Fabry disease Gaucher disease GM1 gangliosidosis lysosomal acid lipase deficiency metachromatic leukodystrophy Mucopolysaccharidosis III Mucopolysaccharidosis IV mucopolysaccharidosis type 2 mucopolysaccharidosis type 3B mucopolysaccharidosis type 4A mucopolysaccharidosis type 6 mucopolysaccharidosis type 7 neuronal ceroid lipofuscinosis 2 Niemann-Pick disease Niemann-Pick disease type C Rare Diseases Wolman disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acid sphingomyelinase deficiency Cerebrotendinous xanthomatosis Ceroid lipofuscinosis, neuronal, 2 Fabry disease Gaucher disease GM1 gangliosidosis Lysosomal acid lipase deficiency Metachromatic leukodystrophy Mucopolysaccharidosis ii Mucopolysaccharidosis iii-B Mucopolysaccharidosis iv A Mucopolysaccharidosis vi Mucopolysaccharidosis vii Niemann-Pick disease, type C

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jack D. Weiler Hospital

    The Bronx, New York, 10461, United States

  • Long Island Jewish Medical Center

    Queens, New York, 11040, United States

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Mount Sinai Hospital

    New York, New York, 10028, United States

  • Mount Sinai West

    New York, New York, 10019, United States

  • NYU Langone Health - Tisch Hospital

    New York, New York, 10016, United States

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • ScreenPlus Coordinating Core, Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.