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

NCT06927037 | Recruiting

• 1 other identifier: 24-2424
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Therapy; NICU Infants

Keywords

Physical Therapy; NICU infants; Parental Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Degree of Parent-Therapist Contact

  From birth to hospital discharge, assessed up to 4 months of life

• Infant Neurobehavior

  Assessed at 34 to 36 weeks postmenstrual age

• Change in Maternal Stress

  From birth to hospital discharge, assessed up to 4 months of life

• Change in Parent Competence

  From birth to hospital discharge, assessed up to 4 months of life

Study Arms (3)

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

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \<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

You may not qualify if:

• Has a high likelihood of transferring to an outside hospital
• Has a genetic abnormality, congenital neurological or musculoskeletal disorder
• Is the biological parent
• Sex is female
• Understands English or Spanish Language
• Is at least 18 years of age
• Is not the biological parent
• Sex is male
• Does not understand English or Spanish language
• Is under 18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation for Physical Therapy Research: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Study Officials

• Dana McCarty, PT, DPT, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)