Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06927037

Conditions

Physical Therapy

NICU Infants

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Physical Therapy

NICU Infants

Study ID

NCT06927037

Start date

Nov 1, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Number of physical therapy visits [ Time Frame: From birth to hospital discharge, assessed up to 4 months of life ]
  • Number of physical therapy minutes billed [ Time Frame: From birth to hospital discharge, assessed up to 4 months of life ]
  • Number of physical therapy interactions by parent [ Time Frame: From birth to hospital discharge, assessed up to 4 months of life ]
  • Infant Motor Skills [ Time Frame: Assessed at 34 to 36 weeks postmenstrual age ]

Central Contacts and Locations

Locations

UNC Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Dana McCarty, PT, DPT, PhD

919-843-8792dana_mccarty@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Physical Therapy
  • NICU infants
  • Parental Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-17.