OBJECTIVE: We conducted a randomized, double-blind, controlled clinical trial to determine whether hyperbaric oxygen (HBO) improves gross motor function in children with cerebral palsy. METHODS:Forty-nine children aged 3 to 8 years with spastic cerebral palsy were randomized to 40 treatments of HBO (100% oxygen at 1.5atm) or hyperbaric air (HBA, 14% oxygen at 1.5atm) over an 8-week period. The primary outcome was the Gross Motor Function Measure (GMFM) global score. Other outcomes included the Pediatric Evaluation of Disability Inventory (PEDI). Assessments were made before and immediately, 3 months, and 6 months after the treatment period. Within-group changes were analyzed with paired t tests or repeated measures analysis of variance. Analysis of covariance was used for between-group comparisons. RESULTS:Forty-six children (24 HBO, 22 HBA) were analyzed at the second interim analysis, which was scheduled to take place when at least half of the required number of patients in each group had completed pre- and post-treatment testing. No changes occurred in the GMFM from pre- to post-treatment in either group or between groups. Statistically significant increases occurred in both groups on the PEDI, with no difference between groups. The study was stopped because the calculated conditional probability of obtaining a difference between groups if the study continued to the end was only between 0.5% and 1.6%. INTERPRETATION:HBO was not effective in improving GMFM scores, and was no more effective than HBA in improving PEDI scores. These results do not support use of HBO as a therapy for cerebral palsy in young children who did not have neonatal hypoxic-ischemic encephalopathy.
RCT Entities:
OBJECTIVE: We conducted a randomized, double-blind, controlled clinical trial to determine whether hyperbaric oxygen (HBO) improves gross motor function in children with cerebral palsy. METHODS: Forty-nine children aged 3 to 8 years with spastic cerebral palsy were randomized to 40 treatments of HBO (100% oxygen at 1.5atm) or hyperbaric air (HBA, 14% oxygen at 1.5atm) over an 8-week period. The primary outcome was the Gross Motor Function Measure (GMFM) global score. Other outcomes included the Pediatric Evaluation of Disability Inventory (PEDI). Assessments were made before and immediately, 3 months, and 6 months after the treatment period. Within-group changes were analyzed with paired t tests or repeated measures analysis of variance. Analysis of covariance was used for between-group comparisons. RESULTS: Forty-six children (24 HBO, 22 HBA) were analyzed at the second interim analysis, which was scheduled to take place when at least half of the required number of patients in each group had completed pre- and post-treatment testing. No changes occurred in the GMFM from pre- to post-treatment in either group or between groups. Statistically significant increases occurred in both groups on the PEDI, with no difference between groups. The study was stopped because the calculated conditional probability of obtaining a difference between groups if the study continued to the end was only between 0.5% and 1.6%. INTERPRETATION: HBO was not effective in improving GMFM scores, and was no more effective than HBA in improving PEDI scores. These results do not support use of HBO as a therapy for cerebral palsy in young children who did not have neonatal hypoxic-ischemicencephalopathy.