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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Degree of Parent-Therapist Contact [Срок оценки: From birth to hospital discharge, assessed up to 4 months of life]
• Infant Neurobehavior [Срок оценки: Assessed at 34 to 36 weeks postmenstrual age]
• Change in Maternal Stress [Срок оценки: From birth to hospital discharge, assessed up to 4 months of life]
• Change in Parent Competence [Срок оценки: From birth to hospital discharge, assessed up to 4 months of life]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• UNC Hospitals — Chapel Hill

Публикации

• 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. PMID 42400089

Идентификаторы

NCT: NCT06927037 · 24-2424

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗