Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Physical Therapy, NICU Infants. Basic parameters: 0 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes
Overview
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.
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.
Primary outcome measures
- Number of physical therapy visits [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
- Number of physical therapy minutes billed [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
- Number of physical therapy interactions by parent [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
- Infant Motor Skills [Time frame: Assessed at 34 to 36 weeks postmenstrual age]
Secondary outcome measures (4)
- Degree of Parent-Therapist Contact [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
- Infant Neurobehavior [Time frame: Assessed at 34 to 36 weeks postmenstrual age]
- Change in Maternal Stress [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
- Change in Parent Competence [Time frame: From birth to hospital discharge, assessed up to 4 months of life]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UNC Hospitals — Chapel Hill
Publications
- McCarty DB, Zadrozny S, Tarnai K, Ustby C, Soucie M, Dusing SC. Immersive physical and occupational therapy in the neonatal intensive care unit: a non-randomized comparative cohort trial protocol. Pilot Feasibility Stud. 2026 Jul 3. doi: 10.1186/s40814-026-01874-y. Online ahead of print. PMID 42400089
Identifiers
NCT: NCT06927037 · 24-2424