Immersive physical and occupational therapy in the neonatal intensive care unit: a non-randomized comparative cohort trial protocol.
Dana B McCarty, Sabrina Zadrozny, Kathryn Tarnai...
https://pubmed.ncbi.nlm.nih.gov/42400089/Actively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17
150
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating how different physical and occupational therapy programs in the Newborn Critical Care Center affect parents stress levels and their ability to care for their preterm infants. The study includes a retrospective group and two prospective groups to evaluate changes over time as hospital initiatives evolve. These initiatives involve changes in care models for infants born before 29 weeks gestation. The study compares three groups one receiving usual care, another cared for in a Small Baby Unit SBU, and a third where parents participate in immersive physical therapy with their infants. These groups correspond to different stages of hospital care improvements. The therapies focus on physical therapy visits, minutes billed, and parent involvement in therapy techniques during the infants hospital stay. Participants will be assessed from birth until hospital discharge, with follow-up up to 4 months of life. Researchers will measure the number of therapy visits and parent interactions, infant motor skills and neurobehavior, as well as changes in maternal stress and parent competence. Data collection includes evaluations at 34 to 36 weeks postmenstrual age, aiming to understand the impact of care models on both infants and their parents.
CONDITIONS
Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)
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University of North Carolina, Chapel Hill
Lead Sponsor
Foundation for Physical Therapy Research
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth to hospital discharge, assessed up to 4 months of life
Participants who undergo routine care are observed to assess physical therapy visits, therapy minutes, and parent-administered interactions from birth to hospital discharge.
Ongoing assessments during hospital stay
Duration - At 34 to 36 weeks postmenstrual age
Participants are assessed for infant motor skills and neurobehavior as well as changes in maternal stress and parent competence at 34 to 36 weeks postmenstrual age.
1 to 2 visits
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Dana B McCarty, Sabrina Zadrozny, Kathryn Tarnai...
https://pubmed.ncbi.nlm.nih.gov/42400089/University of North Carolina, Chapel Hill
Lead Sponsor
Foundation for Physical Therapy Research
Collaborating Sponsor