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NICU study aims to tackle housing and job insecurity for preterm infant families

NCT ID NCT06582147

Knowledge-focused Sponsor: University of Massachusetts, Worcester 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a program called WE CARE in the NICU, which screens families of preterm babies for unmet social needs like housing or job insecurity and provides referrals to community resources. About 882 mothers and their preterm infants (born before 34 weeks) will take part. The goal is to see if this approach helps families get the support they need, potentially improving the babies' long-term health.

What this could mean

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

Active substance
Social determinants of health screening and referral program (WE CARE)
What this could lead to
If successful, this could show that screening for social needs in the NICU helps families get resources, potentially improving long-term health for preterm infants.
What could go wrong
This is an early implementation study, not testing a drug. It may not prove that the program directly improves health outcomes, and results may vary across hospitals.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 882 people

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

Started

Dec 2024

Expected to finish

Dec 2027

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Infant gestational age \<34 weeks' gestation; singleton or multiple. * Infant hospitalized for at least 14 days of life (to allow for SDOH screening/referral and contact with resources if applicable). * Mother and infant are alive. * Mother speaks and reads English or Spanish. * Infant will be discharged home from the NICU (to allow for follow-up). * Mother will care for her infant(s) at home in the US for at least 12 months after discharge from the NICU. Exclusion Criteria: * Mothers or infants who die before anticipated infant discharge. * Infant discharged after 52 weeks postmenstrual age.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Preterm birth

How to take part

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

  1. The places running it

    7 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

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Denver Health Hospital Authority

    Denver, Colorado, 80204, United States

  • Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

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