Clinical trial Recruiting at 1 site Observational Ages 0 to 99

Immersive physical therapy for NICU babies

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

Run by University of North Carolina, Chapel Hill · NCT06927037 · Data updated 2026-11-12

This project will try immersive physical and occupational therapy approaches with parents and very preterm infants (born before 29 weeks) to see if they lower parental stress and help parents meet their infants' needs.

Quick facts

Study typeObservational
Ages0 Years to 99 Years
SexAll
Enrollment150 (estimated)
SponsorUniversity of North Carolina, Chapel Hill
Academic / other
Locations1 site (Chapel Hill, North Carolina)
StatusRecruiting
StartedNovember 1, 2025
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedFebruary 17, 2026
Trial IDNCT06927037 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are biological mothers aged 18 or older who speak English or Spanish and have an infant born before 29 weeks gestation who was born or transferred to UNC's Newborn Critical Care Center within 48 hours of life.

Probably not a fit

Infants with genetic abnormalities or congenital neurological or musculoskeletal disorders, infants likely to transfer to outside hospitals, and parents who are under 18 or do not speak English or Spanish are unlikely to be included or to benefit from this specific program as studied.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a three-group, time-based design tied to the hospital's phased rollout of two standard-of-care initiatives: a retrospective group under current care, a prospective group after implementing a small baby unit (SBU), and a second prospective group after transitioning the SBU to an immersive physical therapy model. Enrollment is determined by when families receive care during these rollouts rather than by random assignment. Data collected will focus on parental stress measures and parents' reported ability to meet infant needs, with eligibility restricted to very preterm infants and their biological mothers who meet language and age criteria. The goal is to capture real-world changes in family experience and caregiving associated with these clinical care models in the Newborn Critical Care Center.

Why it matters

Potential benefit: If successful, the program could reduce parental stress, strengthen parent-infant interactions, and inform NICU care practices that support developmental outcomes for very preterm infants.

How similar studies have gone: Prior small-baby unit and developmental-care programs in NICUs have shown some improvements in parental stress and infant outcomes, but this specific immersive physical therapy model is relatively novel and not yet widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • UNC Hospitals
    Chapel Hill, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Dana McCarty, PT, DPT, PhD — University of North Carolina, Chapel Hill

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.