Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit

Running, not enrolling · Not applicable

Conditions studied: Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia

In brief

Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).

Key facts

Study ID

NCT05568264

Run by

Shirley Ryan AbilityLab

People needed

222

Starts

2022-10-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• (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 it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Northwestern Medicine Prentice Children's Hospital — Chicago, Illinois, United States
• Children's Hospital at the University of Illinois — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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