Clinical trial NCT05568264: Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Official title: Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Delay
Premature Birth
Intraventricular Hemorrhage
Hypoxic-Ischemic Encephalopathy
Bronchopulmonary Dysplasia
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Northwestern University
name: Northwestern Medicine
name: University of Illinois at Chicago
First posted: 2022-10-05
Enrollment: 222
Sex: ALL
Minimum age (years): 33
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified randomized block design, two-arm, parallel assignment
Primary purpose: TREATMENT

Brief summary: Study Aims

Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis.

Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age.

The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\]

Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay.

The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age.

Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being.

The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).

Detailed description: The investigators will conduct a randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. After enrollment, infants will be randomized to an intervention group or a standard of care group.

The intervention will start as early as possible (in the NICU) and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day.

All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.

All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available).

Eligibility criteria: Inclusion Criteria:

NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:

* BW \<1500 grams

OR

* Disorders of the central nervous system

  * Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)

    * HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
    * includes "at risk for HIE" with 10-minute Apgar \<7 plus pH\<7.15 or base deficit \>/=12.
  * Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
  * Cramped synchronous movements at term PMA

OR

* Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation.

AND

* Medically stable AND able to start intervention between 34-48 weeks PMA.

Exclusion Criteria:

(related to inability to complete intervention, sensor placement, or clinic assessments)

* open wounds, skin condition precluding sensor placement
* immune deficiencies requiring protective isolation
* limb reduction defects
* followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
* bleeding disorders or ongoing need for anticoagulation
* palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
* known visual impairment at the time of enrollment
* DCFS custody
* no English-speaking caregivers
* any other condition that would preclude participation in the study, as determined by the PI
* previously enrolled in competing randomized trial with developmental outcome variables

Each child's enrollment in the study will be approved by the child's neonatologist.

Primary outcomes:
measure: Bayley-4 motor score at 12-months corrected age
timeFrame: Bayley-4 motor score assessed at 12-months CA will be the primary outcome
Secondary outcomes:
measure: Movement quality assessed by wearable sensors
timeFrame: At each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (CA), 3-month CA, 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: PedsQL will be completed once during NICU stay (up to 45 days post enrolment), at one-and two-month intervals after enrollment; at 3-month corrected age (CA), 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
measure: Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
timeFrame: The Bayley-4 cognitive score will be assessed at 6-months corrected age (CA), 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Other outcomes:
measure: Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Mobility Domain
timeFrame: The PEDI-CAT will be administered at 12-months corrected age (CA), at 18-months CA (optional), and at 24-months CA (optional).
measure: Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
timeFrame: The WIDEA-FS will be administered at 12-months corrected age (CA), and at 18-months CA (optional) and 24-months CA (optional).
measure: Hammersmith Infant Neurological Exam (HINE)
timeFrame: The HINE will be performed at 3-months corrected age (CA), 6-months CA, 9-months CA, and 12-months CA.
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: The AIMS will be administered at 6-months corrected age (CA), 9-months CA, and 12-months CA
measure: Neurological, Sensory, Motor, Developmental Assessment (NSMDA)
timeFrame: The NSMDA will be administered at 3-months corrected age (CA), 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional). Optional sensor assessments will be performed if (i) the infant's caregiver is willing to participate and (ii)
measure: General Movement Assessment (GMA)
timeFrame: The GMA will be performed at enrollment, at one-month and two-months after enrollment, and at 3-month corrected age (CA). This test may not be scored if performed at 6-8 weeks corrected age, but may videos may be collected to align with sensor data.
measure: Test of Infant Motor Performance (TIMP)
timeFrame: The TIMP will be administered at enrollment, at one- and two-months after enrollment, and at 3-months corrected age (CA)
measure: Bayley-4 Cognitive domain
timeFrame: The Bayley-4 cognitive domain assessment will be administered at 6-months corrected age (CA), 18-months CA (optional), and 24-months CA (optional).
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medicine Prentice Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: Children's Hospital at the University of Illinois
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: