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Can simple play help Brain-Injured babies develop?

NCT ID NCT05130528

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a sensorimotor program for infants with hypoxic-ischemic encephalopathy (HIE), a brain injury from lack of oxygen at birth. Eleven babies received play-based therapy sessions in the NICU and at home for the first 6 months. The goal was to see if the program was feasible and could support development.

What this could mean

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

Active substance
sensorimotor intervention (play-based therapy sessions with parents)
What this could lead to
If it works, this could point toward a simple, parent-led therapy to help babies with HIE reach developmental milestones.
What could go wrong
This was a very small feasibility study with only 11 infants, so results may not apply to all babies. The therapy is supportive, not a cure for brain injury.

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

11 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2024

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

Up to 6 months

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: * Infants with moderate or severe hypoxic-ischemic encephalopathy (HIE) based on the modified Sarnat Exam on admission and has started to receive therapeutic hypothermia for 72 hours. * Cared for in the Newborn and Infant Critical Care Unit (NICCU) at Children's Hospital Los Angeles (CHLA). * Family lives within 60 miles of CHLA. * One parent/legal guardian has provided signed and dated informed consent form agreeing to the child's participation and the parent's own participation. Only infants are considered enrolled in the study. Exclusion Criteria: * Infant born preterm. * Infant with congenital anomalies, chromosomal or microarray abnormalities. * Infant with microcephaly. * Infants who have been redirected for comfort care. * Infants who are medically unstable.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia cerebral palsy perinatal asphyxia

As listed by the trial registrant

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

Cerebral palsy Hypoxic-ischemic encephalopathy

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    Los Angeles, California, 90033, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

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