Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay.

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.

Caregiver Concerns About Child Development During the COVID-19 Pandemic among those with Missed Appointments: Preliminary Results.

Introduction: To examine caregiver's perception of their child falling behind on developmental milestones after canceled or delayed appointments in metropolitan Chicago during stay-at-home orders, from March 21-May 7, 2020. Methods: We fielded a web-based caregiver survey to understand the impact of the early weeks of the COVID-19 pandemic on children's health care experiences characterizing proportions of caregiver perceptions of children falling behind in developmental milestones by canceled or delayed appointment types. Multivariable logistic regression was used to estimate the likelihood of falling behind in milestones . Results: Overall, 229 (7.5%) caregivers reported children with canceled or delayed appointments falling behind in developmental milestones. Approximately 25.4% of caregivers reported children falling behind on milestones in the Missed Therapeutic group, compared with the Other Missed group (2.9%) (p<0.001). Children in the Missed Therapeutic group (adjusted odds ratio (aOR) 10.3, 95% confidence interval (CI) 7.60-14.0)) and caregivers who experienced job loss (aOR 1.59, CI 1.11-2.28) or reduced hours or pay (aOR 1.90, CI 1.28-2.82) had higher odds of falling behind on developmental milestones. Conclusions: Implementation of new strategies to address the social needs of families should be develop when disruptions in developmental or therapeutic services among children occurs, particularly among children living in households with job insecurity.