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Can daily sensory activities boost preterm baby brain development?

NCT ID NCT05230199

Knowledge-focused Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a structured program called SENSE, where parents provide daily multisensory activities like massage, rocking, and skin-to-skin care for their preterm babies in the NICU. The goal is to see if this consistent approach improves infant brain development, language skills, and parent-child bonding up to age 2. About 215 infants born at or before 32 weeks will take part, with half receiving the SENSE program and half getting standard care.

What this could mean

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

Active substance
SENSE multisensory program (behavioral intervention involving massage, auditory exposure, rocking, holding, and skin-to-skin care)
What this could lead to
If successful, this could provide a clear, evidence-based guide for parents and hospitals to support preterm infant brain development and parent well-being.
What could go wrong
This is an early-stage study with 215 participants, so results may not apply to all preterm infants. The program requires consistent parent involvement, which may be challenging for some families.

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 215 people

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

Started

May 2023

Expected to finish

Dec 2028

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

1 day to 7 days

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 Criteria: * ≤ 32 weeks estimated gestational age (EGA) * recruited within the first week of life Exclusion Criteria: * \> 32 weeks EGA at birth * \>7 days old * become wards of the state * have a suspected or confirmed congenital anomaly * face a high immediate threat of death, per the opinion of the attending physician.

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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.

Development, infant Parent-child relations Parents Preterm Sensory integration dysfunction

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Cardinal Glennon Children's Hospital

    RECRUITING

    St Louis, Missouri, 63104, United States

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