Clinical trial NCT06927037: Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)
Official title: Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Physical Therapy
NICU Infants
Keywords: Physical Therapy
NICU infants
Parental Stress
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy Research
First posted: 2025-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility criteria: Infant Inclusion Criteria:

* \<28 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

Primary outcomes:
measure: Number of physical therapy visits
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
measure: Number of physical therapy minutes billed
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
measure: Number of physical therapy interactions by parent
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
measure: Infant Motor Skills
timeFrame: Assessed at 34 to 36 weeks postmenstrual age
Secondary outcomes:
measure: Degree of Parent-Therapist Contact
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
measure: Infant Neurobehavior
timeFrame: Assessed at 34 to 36 weeks postmenstrual age
measure: Change in Maternal Stress
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
measure: Change in Parent Competence
timeFrame: From birth to hospital discharge, assessed up to 4 months of life
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Dana McCarty, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: