Early Protocolized Rehabilitation Versus Usual Care in Improving Functional Outcomes in Pediatric Neurocritical Patients: A Randomized Controlled Trial.

Background: An early protocolized rehabilitation (EPR) program has the potential to improve functional outcomes in pediatric neurocritical care patients in the pediatric intensive care unit over standard care alone. However, this requires validation through a randomized controlled trial (RCT).

Methods: This single-blind, parallel-design, two-arm RCT evaluated the efficacy of EPR in improving functional outcomes at 24 weeks in pediatric neurocritical patients aged 1-18 years compared to usual care. The study also aimed to compare adaptive function, gross motor function, language skills, cognition, behavioral issues, sleep patterns, quality of life, and family functional outcomes between the two groups. EPR was initiated within 72 h of mechanical ventilation and was customized for each patient by a team of specialists in pediatric neurology, physical medicine and rehabilitation, and speech and language pathology. Rehabilitation sessions were conducted daily for one week, then three times a week for one month, and monthly after discharge, supplemented with weekly teleconsultations.

Results: A total of 196 patients were enrolled (98 in each arm). At 24 weeks, the Pediatric Cerebral Performance Category score was significantly better in the intervention arm (mean difference 0.133 [95% confidence interval 0.055-0.205], p < 0.001). Additionally, improvements were noted in the EPR arm across Child Behavior Checklist, Vineland Adaptive Behavior Scale, Children's Sleep Habits Questionnaire, Pediatric Quality of Life Inventory, and Family Assessment Device scores (p < 0.001 for all).

Conclusions: EPR in pediatric neurocritical patients significantly improves functional outcomes and quality of life at 24 weeks compared to usual care.