Immersive physical therapy for NICU babies
Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes
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 type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06927037 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chapel Hill, North Carolina
- UNC Hospitals — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Dana McCarty, PT, DPT, PhD — University of North Carolina, Chapel Hill
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.