Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-99
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
<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
Disqualifiers
Has a high likelihood of transferring to an outside hospital
Has a genetic abnormality, congenital neurological or musculoskeletal disorder
Is the biological parent
Sex is female
Trial population
Infants and parents identified as part of the NICU at certain University of North Carolina (UNC) Hospital locations
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Usual Care
Group B: Small Baby Unit
Group C: Immersive Physical Therapy
Trial outcomes
Primary outcomes
1
Number of physical therapy visits
The number of physical therapy visits to the infant's bedside per week, as noted in the medical record
Time frame
From birth to hospital discharge, assessed up to 4 months of life2
Number of physical therapy minutes billed
The number of physical therapy minutes billed per week as noted in the medical record
Time frame
From birth to hospital discharge, assessed up to 4 months of life3
Number of physical therapy interactions by parent
The number of times per week that mothers report doing physical therapy with their infant, with higher numbers indicating a greater dosage
Time frame
From birth to hospital discharge, assessed up to 4 months of life4
Infant Motor Skills
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.
Time frame
Assessed at 34 to 36 weeks postmenstrual ageSecondary outcomes
1
Degree of Parent-Therapist Contact
The number of times per week that the parent received education on physical therapy techniques as documented in clinical notes
Time frame
From birth to hospital discharge, assessed up to 4 months of life2
Infant Neurobehavior
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.
Time frame
Assessed at 34 to 36 weeks postmenstrual age3
Change in Maternal Stress
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
Time frame
From birth to hospital discharge, assessed up to 4 months of life4
Change in Parent Competence
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
Time frame
From birth to hospital discharge, assessed up to 4 months of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Foundation for Physical Therapy Research
Collaborator
Source ClinicalTrials.gov