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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06927037
Enrollment
150
Registered
2025-04-15
Start date
2025-11-01
Completion date
2027-06-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NICU Infants, Physical Therapy

Keywords

Physical Therapy, NICU infants, Parental Stress

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.

Interventions

None listed

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER
Foundation for Physical Therapy Research
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Years to 99 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of physical therapy visitsFrom birth to hospital discharge, assessed up to 4 months of lifeThe number of physical therapy visits to the infant's bedside per week, as noted in the medical record
Number of physical therapy minutes billedFrom birth to hospital discharge, assessed up to 4 months of lifeThe number of physical therapy minutes billed per week as noted in the medical record
Number of physical therapy interactions by parentFrom birth to hospital discharge, assessed up to 4 months of lifeThe number of times per week that mothers report doing physical therapy with their infant, with higher numbers indicating a greater dosage
Infant Motor SkillsAssessed at 34 to 36 weeks postmenstrual ageMotor skills will be measured via the Test of Infant Motor Performance, a 42-item test of functional motor skills with age standards from 34 weeks post-menstrual age through 17 weeks post-term. Scores range from 0 to 142 with higher scores indicating better performance. Scores are transformed into an age standard based on performance.

Secondary

MeasureTime frameDescription
Degree of Parent-Therapist ContactFrom birth to hospital discharge, assessed up to 4 months of lifeThe number of times per week that the parent received education on physical therapy techniques as documented in clinical notes
Infant NeurobehaviorAssessed at 34 to 36 weeks postmenstrual ageNeurobehavior will be measured via the NeoNatal Neurobehavioral Scales-II, a valid and reliable neurobehavioral assessment for high-risk infants across 13 different scales, including habituation, attention, arousal, self-regulation, and more. Due to the varied performance across these scales and their different ranges, it can be challenging to determine an overall exam response for each infant. Therefore, grouping response patterns into discrete profiles through latent profile analysis offers a simpler way to compare NNNS performance among infants.
Change in Maternal StressFrom birth to hospital discharge, assessed up to 4 months of lifeMaternal Stress will be measured via the Parent Stress Scale: NICU, a 26-item tool to assess parent stress in NICU that covers topics such as: Infant Appearance, Parental Role Alteration, Sights \& Sounds. Scores range from 0 to 130 with higher scores indicating greater stress
Change in Parent CompetenceFrom birth to hospital discharge, assessed up to 4 months of lifeParent Competence will be measured via the Parent Sense of Competence Scale,17-item scale to assess change in the parent's sense of competence in infant care. Scores range from 17 to 102 with higher scores indicating higher sense of competence

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDana McCarty, PT, DPT, PhD

University of North Carolina, Chapel Hill

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 5, 2026