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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT05568264
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia
  • Hypoxic-Ischemic Encephalopathy
  • Intraventricular Hemorrhage
  • Motor Delay
  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
33 Weeks - 48 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Physical Therapy intervention — OTHER
    The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.

Study Details

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 Dates

Start date
Oct 1, 2022
Status verified
May 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Physical Therapy Intervention
    Infants enrolled in this arm will receive the intervention in addition to standard of care
  • No Intervention: Standard of Care
    Infants enrolled in this arm will receive standard of care

Primary Outcome Measure

Bayley-4 motor score at 12-months corrected age [ Time Frame: Bayley-4 motor score assessed at 12-months CA will be the primary outcome ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Project Manager
[email protected]
Children's Hospital at the University of IllinoisChicagoIllinois60612
Research Associate
[email protected]
312-355-4038
Northwestern Medicine Prentice Children's HospitalChicagoIllinois60611
Project Manager
[email protected]

Find similar trials in Chicago, IL

By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILChildren's Hospital at the University of Illinois· Chicago, ILNorthwestern Medicine Prentice Children's Hospital· Chicago, IL

Related Studies