Physical therapy intervention for infants with motor delays in the NICU
Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
This study is testing a new physical therapy program for babies with motor delays in the NICU to see if it helps them move better compared to just the usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 33 Weeks to 48 Weeks |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05568264 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the efficacy of a physical therapy intervention designed to improve motor function and reduce motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention will begin as early as possible in the NICU and continue until the infants reach 12 months corrected age, involving up to two therapist visits per week alongside standard care. Caregivers will be actively engaged in the therapy process, working with therapists to incorporate therapeutic activities into their daily routines. The study will compare outcomes between infants receiving the intervention and those receiving standard care.
Who should consider this trial
Good fit: Ideal candidates include infants admitted to the NICU who are at risk for motor delays due to low birth weight or central nervous system disorders.
Not a fit: Patients who are not admitted to the NICU or do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance motor development in infants at risk for motor delays.
How similar studies have performed: Other studies have shown promising results with early physical therapy interventions for similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois and 2 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern Medicine Prentice Children's Hospital — Chicago, Illinois, United States (Recruiting)
- Children's Hospital at the University of Illinois — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
- Study coordinator: Elizabeth Hoffman, DPT
- Email: ehoffman@sralab.org
- Phone: 312-238-7711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.