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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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

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Physical Therapy NICU Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Usual Care

A retrospective group of infants whose data represent usual care

No interventions assigned to this group

Small Baby Unit

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

* Is the biological parent
* Sex is female
* Understands English or Spanish Language
* Is at least 18 years of age

Exclusion Criteria

* Has a high likelihood of transferring to an outside hospital
* Has a genetic abnormality, congenital neurological or musculoskeletal disorder

* Is not the biological parent
* Sex is male
* Does not understand English or Spanish language
* Is under 18 years of age

Minimum Eligible Age

0 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No