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Brain scans in the NICU could help protect preemie brains

NCT ID NCT06052865

Knowledge-focused Sponsor: Brigham and Women's Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses repeated MRI scans to track brain injury and growth in very preterm babies (born before 33 weeks) during their NICU stay. Researchers will also test a program called SENSE-plus, which involves daily gentle sensory activities like touch and sound, to see if it helps brain development. The goal is to better identify high-risk infants and guide early interventions to improve their long-term outcomes.

What this could mean

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

Active substance
SENSE-plus (SENSE II program) - a behavioral intervention involving daily sensory exposures for preterm infants
What this could lead to
If successful, this could help doctors identify preterm infants at highest risk for brain injury early, and tailor rehabilitation to improve their development.
What could go wrong
This is an observational study with a small group (75 infants) and no control group, so results may not apply to all preterm babies. The intervention is exploratory and not proven to change outcomes.

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 75 people

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

Started

Sep 2020

Expected to finish

Sep 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.

Ages

22 to 33 weeks

Sex

Anyone

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 * currently admitted to the BWH NICU * born before 33 weeks completed gestational age * birth weight 0.5-4.5 kg * is stable condition per clinical care team Exclusion * confirmed or suspected congenital anomaly or genetic syndrome * congenital TORCH infection

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Conditions

The condition(s) this trial relates to.

brain injury Premature Birth

As listed by the trial registrant

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

Preterm birth complication

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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