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).
BW <1500 grams
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
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)
Parallel
Physical Therapy intervention
Other interventionThe intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start 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. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.
Bayley-4 motor score at 12-months corrected age
The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
Movement quality assessed by wearable sensors
Wireless, lightweight sensors that record continuous, real-time movement information will be applied to the infant's limbs, head, and upper torso at standardized locations either before, during, or after motor assessments. Up to 10 sensors will be applied. The infant's movements will be recorded in various postures, as appropriate to the age/abilities of the infant, such as: supine, prone, pull-to-sit/sitting, standing, and ventral suspension.
Pediatric Quality of Life Inventory (PedsQL)
This 36-item module measures parent self-reported functioning in physical (6 items), emotional (5 items), social (4 items), and cognitive (5 items) domains, communication (3 items), and worry (5 items), as well as two scales measuring parent-reported family functioning: daily activities (3 items) and family relationships (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
The cognitive section is part of a larger assessment that also covers language and motor skills. It is commonly used to determine developmental delays in children aged between 16 days and 42 months. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Mobility Domain
The PEDI-CAT measures abilities in three functional domains: daily activities, mobility, and social/cognitive. The PEDI-CAT can be used in participants from birth to 20 years of age. It is used to identify functional delay and to determine effects of an intervention. The PEDI-CAT mobility domain, which will be administered in this study, comprises items in several content areas, including basic movement, standing and walking, steps and inclines, and running and playing. The survey is completed by the caregiver. The PEDI-CAT scores range from 20-80. A higher score indicates better functional ability.
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
WIDEA-FS assesses a child's adaptive skills in everyday contexts and it is completed by the caregiver. It evaluates four domains, including: mobility (9 items), communication (13 items), social cognition (11 items), and self-care (17 items). The total score for each domain ranges from 50-200 points. A higher score indicates better skills in that domain.
Hammersmith Infant Neurological Exam (HINE)
The HINE comprises 26-items, spanning five domains: cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Each item is given a score between 0 and 3 based on a rubric, with a minimum possible score of 0 and a maximum score of 78. A higher score indicates better neurological performance.
Alberta Infant Motor Scale (AIMS)
The AIMS is a norm referenced, standardized, gross motor assessment. Infants are observed in four positions: prone, sitting, supine, and standing. For each subscale, items are scored as "observed" or "not observed". Scores from each subscale are added to achieve the total AIMS score. The minimum total score is 0 and the maximum is 58. A higher score indicates more advanced neurological development
Click on the lead sponsor to view all of their trials.
Shirley Ryan AbilityLab
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator
Northwestern University
Collaborator
Northwestern Medicine
Collaborator
University of Illinois at Chicago
Collaborator
