Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)

Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes

To learn if and how the physical and occupational therapy program in the Newborn Critical Care Center helps parents with their stress levels and ability to meet the needs of their preterm infants.

Study Overview

• Status: Recruiting
• Conditions: Physical Therapy; NICU Infants

Detailed Description

Composed of one retrospective group and two prospective groups. Each group will be defined based on the stage of enrollment, which will coincide with the rollout of two different standard-of-care initiatives in the hospital. These initiatives are determined outside of the study protocol. The retrospective group will be composed of infants that are under the current initiative. The small baby unit will then be implemented within the hospital site, and infants and parents enrolled at that time will reflect the impact of the small baby unit. The small baby unit will then transition into an immersive physical therapy model, and any infants and parents enrolled at that time will reflect the impact of this second-tier initiative.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Hospitals
      • Contact: Dana McCarty, PT, DPT, PhD; Phone Number: 919-843-8792; Email: dana_mccarty@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations

Description

Infant Inclusion Criteria:

• <29 weeks gestation at birth
• born or transferred to UNC's Newborn Critical Care Center within the first 48 hours of life
• If in the SBU or Immersive PT groups: Must be cared for at certain UNC Hospital locations through at least 34 weeks postmenopausal age

Infant Exclusion Criteria:

• Has a high likelihood of transferring to an outside hospital
• Has a genetic abnormality, congenital neurological or musculoskeletal disorder

Maternal Inclusion Criteria:

• Is the biological parent
• Sex is female
• Understands English or Spanish Language
• Is at least 18 years of age

Maternal Exclusion Criteria:

• Is not the biological parent
• Sex is male
• Does not understand English or Spanish language
• Is under 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Usual Care; A retrospective group of infants whose data represent usual care
Small Baby Unit; A group comprised of infants and their parents that represent implementation of a Small Baby Unit (SBU)
Immersive Physical Therapy; A group comprised of infants and their parents that represent the small baby unit where parents are also asked to administer physical therapy techniques with their infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of physical therapy visits	The number of physical therapy visits to the infant's bedside per week, as noted in the medical record	From birth to hospital discharge, assessed up to 4 months of life
Number of physical therapy minutes billed	The number of physical therapy minutes billed per week as noted in the medical record	From birth to hospital discharge, assessed up to 4 months of life
Number of physical therapy interactions by parent	The number of times per week that mothers report doing physical therapy with their infant, with higher numbers indicating a greater dosage	From birth to hospital discharge, assessed up to 4 months of life
Infant Motor Skills	Motor skills will be measured via the Test of Infant Motor Performance, a 42-item test of functional motor skills with age standards from 34 weeks post-menstrual age through 17 weeks post-term. Scores range from 0 to 142 with higher scores indicating better performance. Scores are transformed into an age standard based on performance.	Assessed at 34 to 36 weeks postmenstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Parent-Therapist Contact	The number of times per week that the parent received education on physical therapy techniques as documented in clinical notes	From birth to hospital discharge, assessed up to 4 months of life
Change in Maternal Stress	Maternal Stress will be measured via the Parent Stress Scale: NICU, a 26-item tool to assess parent stress in NICU that covers topics such as: Infant Appearance, Parental Role Alteration, Sights & Sounds. Scores range from 0 to 130 with higher scores indicating greater stress	From birth to hospital discharge, assessed up to 4 months of life
Change in Parent Competence	Parent Competence will be measured via the Parent Sense of Competence Scale,17-item scale to assess change in the parent's sense of competence in infant care. Scores range from 17 to 102 with higher scores indicating higher sense of competence	From birth to hospital discharge, assessed up to 4 months of life
Infant Neurobehavior	Neurobehavior will be measured via the NeoNatal Neurobehavioral Scales-II, a valid and reliable neurobehavioral assessment for high-risk infants across 13 different scales, including habituation, attention, arousal, self-regulation, and more. Due to the varied performance across these scales and their different ranges, it can be challenging to determine an overall exam response for each infant. Therefore, grouping response patterns into discrete profiles through latent profile analysis offers a simpler way to compare NNNS performance among infants.	Assessed at 34 to 36 weeks postmenstrual age

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Foundation for Physical Therapy Research
• Investigators: Principal Investigator: Dana McCarty, PT, DPT, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Therapy; Parental Stress; NICU infants
• Other Study ID Numbers: 24-2424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No