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| Name | Class |
|---|---|
| Foundation for Physical Therapy Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | A retrospective group of infants whose data represent usual care | ||
| Small Baby Unit | A group comprised of infants and their parents that represent implementation of a Small Baby Unit (SBU) | ||
| Immersive Physical Therapy | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of physical therapy visits | The number of physical therapy visits to the infant's bedside per week, as noted in the medical record | 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 | 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 | 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. | Assessed at 34 to 36 weeks postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From birth to hospital discharge, assessed up to 4 months of life |
| Infant Neurobehavior |
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Infant Inclusion Criteria:
Infant Exclusion Criteria:
Maternal Inclusion Criteria:
Maternal Exclusion Criteria:
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Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations
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| Name | Affiliation | Role |
|---|---|---|
| Dana McCarty, PT, DPT, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42400089 | Derived | 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. |
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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. |
| 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 | 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 | From birth to hospital discharge, assessed up to 4 months of life |