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NCT Number: NCT06927037

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

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.

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Key information

Conditions

Physical Therapy NICU Infants

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Dana McCarty, PT, DPT, PhD

CONTACT

[email protected]

919-843-8792

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. Degree of Parent-Therapist Contact

    Time frame: From birth to hospital discharge, assessed up to 4 months of life

    The number of times per week that the parent received education on physical therapy techniques as documented in clinical notes

  2. Infant Neurobehavior

    Time frame: Assessed at 34 to 36 weeks postmenstrual age

    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.

  3. Change in Maternal Stress

    Time frame: From birth to hospital discharge, assessed up to 4 months of life

    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

  4. Change in Parent Competence

    Time frame: From birth to hospital discharge, assessed up to 4 months of life

    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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Foundation for Physical Therapy Research

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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