An observational study in Physical Therapy and NICU Infants, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 0 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of North Carolina, Chapel Hill · Observational
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.
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations
Infant Inclusion Criteria:
Infant Exclusion Criteria:
Maternal Inclusion Criteria:
Maternal Exclusion Criteria:
A retrospective group of infants whose data represent usual care
A group comprised of infants and their parents that represent implementation of a Small Baby Unit (SBU)
A group comprised of infants and their parents that represent the small baby unit where parents are also asked to administer physical therapy techniques with their infants
Number of physical therapy visits
The number of physical therapy visits to the infant's bedside per week, as noted in the medical record
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Number of physical therapy minutes billed
The number of physical therapy minutes billed per week as noted in the medical record
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Number of physical therapy interactions by parent
The number of times per week that mothers report doing physical therapy with their infant, with higher numbers indicating a greater dosage
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Infant Motor Skills
Motor 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.
Time frame: Assessed at 34 to 36 weeks postmenstrual age
Degree of Parent-Therapist Contact
The number of times per week that the parent received education on physical therapy techniques as documented in clinical notes
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Infant Neurobehavior
Neurobehavior 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.
Time frame: Assessed at 34 to 36 weeks postmenstrual age
Change in Maternal Stress
Maternal 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
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Change in Parent Competence
Parent 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
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Plan to share: No
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University of North Carolina, Chapel Hill