Early therapy may rewire motor development in premature infants
NCT ID NCT05568264
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 222 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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33 to 48 weeks
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
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Children's Hospital at the University of Illinois
Chicago, Illinois, 60612, United States
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Northwestern Medicine Prentice Children's Hospital
Chicago, Illinois, 60611, United States
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