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Early therapy may rewire motor development in premature infants

NCT ID NCT05568264

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether starting physical therapy early—while infants are still in the NICU and continuing until 12 months corrected age—can improve motor function and reduce the severity of motor delays in babies at high risk due to premature birth, brain injury, or other conditions. Infants in the intervention group receive up to two extra therapist visits per week, plus caregiver-guided activities, compared to standard care. The study measures motor skills at 12 months and also checks for earlier improvements and caregiver well-being.

What this could mean

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

Active substance
Physical therapy intervention
What this could lead to
If effective, this early intervention could improve motor outcomes and reduce disability in infants at high risk for motor delays.
What could go wrong
The trial is early and may not show a significant benefit. The intervention requires caregiver commitment, and results may not apply to all infants.

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 222 people

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

Started

Oct 2022

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

33 to 48 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 Criteria: NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to: * BW \<1500 grams OR * Disorders of the central nervous system * Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis) * HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled * includes "at risk for HIE" with 10-minute Apgar \<7 plus pH\<7.15 or base deficit \>/=12. * Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis) * Cramped synchronous movements at term PMA OR * Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation. AND * Medically stable AND able to start intervention between 34-48 weeks PMA. Exclusion Criteria: (related to inability to complete intervention, sensor placement, or clinic assessments) * open wounds, skin condition precluding sensor placement * immune deficiencies requiring protective isolation * limb reduction defects * followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21) * bleeding disorders or ongoing need for anticoagulation * palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13) * known visual impairment at the time of enrollment * DCFS custody * no English-speaking caregivers * any other condition that would preclude participation in the study, as determined by the PI * previously enrolled in competing randomized trial with developmental outcome variables Each child's enrollment in the study will be approved by the child's neonatologist.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Children's Hospital at the University of Illinois

    Chicago, Illinois, 60612, United States

  • Northwestern Medicine Prentice Children's Hospital

    Chicago, Illinois, 60611, United States

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