Physical TherapyNCT06927037
Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)
An observational study of Physical Therapy and NICU Infants, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Physical Therapy, NICU Infants
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations
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 Exclusion Criteria:
- Is not the biological parent
- Sex is male
- Does not understand English or Spanish language
- Is under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Hospitals
Chapel Hill, North Carolina, 27599
Dana McCarty, PT, DPT, PhD, 919-843-8792, dana_mccarty@med.unc.edu
About this study
Official title: Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes
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.
Read the 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.
- Conditions
- Physical Therapy, NICU Infants
- Keywords
- Physical Therapy, NICU infants, Parental Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of physical therapy visits
The number of physical therapy visits to the infant's bedside per week, as noted in the medical record
Measured: 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
Measured: 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
Measured: 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.
Measured: Assessed at 34 to 36 weeks postmenstrual age
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: From birth to hospital discharge, assessed up to 4 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Responsible party
- Sponsor
- Investigators
- Dana McCarty, PT, DPT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927037
- Sponsor's protocol ID
- 24-2424
- Status last verified
- Feb 2026
- First submitted
- 3 Apr 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42400089
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Physical Therapy in the NICU: Comparing Delivery Models to Improve Infant and Parent Outcomes
- ClinicalTrials.gov ID
- NCT06927037
- Acronym / sponsor ID
- 24-2424
- Conditions
- Physical Therapy, NICU Infants
- Keywords
- Physical Therapy, NICU infants, Parental Stress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of physical therapy visits
Time frame: From birth to hospital discharge, assessed up to 4 months of life
The number of physical therapy visits to the infant's bedside per week, as noted in the medical record
Number of physical therapy minutes billed
Time frame: From birth to hospital discharge, assessed up to 4 months of life
The number of physical therapy minutes billed per week as noted in the medical record
Number of physical therapy interactions by parent
Time frame: From birth to hospital discharge, assessed up to 4 months of life
The number of times per week that mothers report doing physical therapy with their infant, with higher numbers indicating a greater dosage
Infant Motor Skills
Time frame: Assessed at 34 to 36 weeks postmenstrual age
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.
4 secondary outcomes
Degree of Parent-Therapist Contact
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Infant Neurobehavior
Time frame: Assessed at 34 to 36 weeks postmenstrual age
Change in Maternal Stress
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Change in Parent Competence
Time frame: From birth to hospital discharge, assessed up to 4 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42400089McCarty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dana McCarty, PT, DPT, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Therapy and NICU Infants, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of physical therapy visits (time frame: From birth to hospital discharge, assessed up to 4 months of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.