Actively Recruiting

Age: 0Years - 99Years
All Genders
ID06927037

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

F

Foundation for Physical Therapy Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how different physical and occupational therapy programs in the Newborn Critical Care Center affect parents' stress levels and their ability to care for their preterm infants. The study includes a retrospective group and two prospective groups to evaluate changes over time as hospital initiatives evolve. These initiatives involve changes in care models for infants born before 29 weeks gestation. The study compares three groups: one receiving usual care, another cared for in a Small Baby Unit (SBU), and a third where parents participate in immersive physical therapy with their infants. These groups correspond to different stages of hospital care improvements. The therapies focus on physical therapy visits, minutes billed, and parent involvement in therapy techniques during the infant's hospital stay. Participants will be assessed from birth until hospital discharge, with follow-up up to 4 months of life. Researchers will measure the number of therapy visits and parent interactions, infant motor skills and neurobehavior, as well as changes in maternal stress and parent competence. Data collection includes evaluations at 34 to 36 weeks postmenstrual age, aiming to understand the impact of care models on both infants and their parents.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant born before 29 weeks gestation
  • Infant born or transferred to UNC's Newborn Critical Care Center within 48 hours of life
  • For Small Baby Unit or Immersive Physical Therapy groups: Infant cared for at specific UNC Hospital locations through at least 34 weeks postmenstrual age
  • Biological mother of the infant
  • Female sex
  • Understands English or Spanish
  • At least 18 years old
Not Eligible

You will not qualify if you...

  • Infant likely to transfer to an outside hospital
  • Infant has a genetic abnormality, congenital neurological, or musculoskeletal disorder
  • Not the biological parent
  • Male sex
  • Does not understand English or Spanish
  • Under 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Participants who undergo routine care are observed to assess physical therapy visits, therapy minutes, and parent-administered interactions from birth to hospital discharge.

Ongoing assessments during hospital stay

Long-term Monitoring

Duration - At 34 to 36 weeks postmenstrual age

Participants are assessed for infant motor skills and neurobehavior as well as changes in maternal stress and parent competence at 34 to 36 weeks postmenstrual age.

1 to 2 visits

Trial Site Locations

Total: 1 location

1

UNC Hospitals

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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