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

Premature Birth Clinical Trial

Official title: Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

The investigators will conduct a randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. After enrollment, infants will be randomized to an intervention group or a standard of care group.

The intervention will start as early as possible (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.

All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.

All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available). ;

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Bronchopulmonary Dysplasia
• Hemorrhage
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Intraventricular Hemorrhage
• Motor Delay
• Motor Skills Disorders
• Premature Birth

• NCT number: NCT05568264
• Study type: Interventional
• Source: Shirley Ryan AbilityLab
• Contact: Sofia Anastasopoulos, DPT
• Phone: 312-238-1173
• Email: sanastasop@sralab.org
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Completion date: December 31, 2026