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Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical
Weiyang Deng1, Sofia Anastasopoulos1, Raye-Ann deRegnier2,3
1Shirley Ryan AbilityLab, Chicago, Illinois, United States of America.
Insights
Early physical therapy for infants at risk of neuromotor delay, starting in the NICU, may improve motor development. This intervention harnesses infant neuroplasticity for better long-term outcomes.
Area of Science:
- Pediatric Physical Therapy
- Infant Neuromotor Development
- Early Intervention
Background:
- Developmental disabilities and neuromotor delay negatively impact long-term health and quality of life.
- Early therapeutic interventions can mitigate motor delays by leveraging infant neuroplasticity.
- Existing interventions often start late and are short-term, missing critical early neuroplastic windows.
Purpose of the Study:
- To evaluate the efficacy of an early, intensive physical therapy intervention for infants at risk of neuromotor delay.
- To assess the impact of an intervention initiated in the neonatal intensive care unit (NICU) and continued to 12 months corrected age.
- To investigate the benefits of a multi-component intervention integrating active learning, environmental enrichment, and caregiver engagement.
Main Methods:
- A multi-site longitudinal randomized controlled trial involving 192 infants at risk for neuromotor delay.
- Randomization to either standard-of-care or an intensive physical therapy intervention (twice-weekly sessions, daily caregiver activities).
- Comprehensive neuromotor assessment using standardized clinical tools and novel technology-based methods.
Main Results:
- The primary outcome is the Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4) motor score at 12 months corrected age.
- Comparison of motor scores between the intervention and standard-of-care groups will determine efficacy.
- Longitudinal data collection will track neuromotor status and development throughout the study period.
Conclusions:
- This study will provide crucial evidence on the effectiveness of early, high-dosage physical therapy for infants identified with neuromotor delay risk.
- Findings may inform clinical practice guidelines for early intervention in neonatal intensive care units.
- Successful outcomes could lead to improved long-term neuromuscular function and quality of life for affected children.
Introduction:
Developmental disabilities and neuromotor delay adversely affect long-term neuromuscular function and quality of life. Current evidence suggests that early therapeutic intervention reduces the severity of motor delay by harnessing neuroplastic potential during infancy. To date, most early therapeutic intervention trials are of limited duration and do not begin soon after birth and thus do not take full advantage of early neuroplasticity. The Corbett Ryan-Northwestern-Shirley Ryan AbilityLab-Lurie Children's Infant Early Detection, Intervention and Prevention Project (Project Corbett Ryan) is a multi-site longitudinal randomized controlled trial to evaluate the efficacy of an evidence-based physical therapy intervention initiated in the neonatal intensive care unit (NICU) and continuing to 12 months of age (corrected when applicable). The study integrates five key principles: active learning, environmental enrichment, caregiver engagement, a strengths-based approach, and high dosage (ClinicalTrials.gov identifier NCT05568264).
Methods:
We will recruit 192 infants at risk for neuromotor delay who were admitted to the NICU. Infants will be randomized to either a standard-of-care group or an intervention group; infants in both groups will have access to standard-of-care services. The intervention is initiated in the NICU and continues in the infant's home until 12 months of age. Participants will receive twice-weekly physical therapy sessions and caregiver-guided daily activities, assigned by the therapist, targeting collaboratively identified goals. We will use various standardized clinical assessments (General Movement Assessment; Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4); Test of Infant Motor Performance; Pediatric Quality of Life Inventory Family Impact Module; Alberta Infant Motor Scale; Neurological, Sensory, Motor, Developmental Assessment; Hammersmith Infant Neurological Examination) as well as novel technology-based tools (wearable sensors, video-based pose estimation) to evaluate neuromotor status and development throughout the course of the study. The primary outcome is the Bayley-4 motor score at 12 months; we will compare scores in infants receiving the intervention vs. standard-of-care therapy.
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