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

University of North Carolina (UNC)

Status: Begins enrollment this month

Conditions: NICU Infants; Physical Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06927037

24-2424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Infant Inclusion Criteria:

• <28 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 design

150 participants in 3 patient groups

Usual Care

Description:

A retrospective group of infants whose data represent usual care

Small Baby Unit

Description:

A group comprised of infants and their parents that represent implementation of a Small Baby Unit (SBU)

Immersive Physical Therapy

Description:

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