A randomized clinical trial of regional cerebral perfusion versus deep hypothermic circulatory arrest: outcomes for infants with functional single ventricle.

OBJECTIVE: Regional cerebral perfusion has been adopted as a means to improve neuroprotection during aortic arch reconstruction. The purpose of this study was to determine whether a strategy of regional cerebral perfusion rather than one of deep hypothermic circulatory arrest during aortic arch reconstruction would improve neurodevelopment without increasing morbidity or mortality for patients undergoing the Norwood operation.
METHODS: A randomized trial was performed in infants with single ventricle anatomy undergoing the Norwood operation. Participants were randomized to deep hypothermic circulatory arrest or regional cerebral perfusion. Neurodevelopment was measured before second-stage surgery and at 1 year by the Bayley Scales of Infant Development-II, Psychomotor Development Index and Mental Development Index. Intent-to-treat analysis was performed.
RESULTS: Seventy-seven patients were enrolled. Survival to hospital discharge was 88% and to 1-year follow-up, 75%, without a significant difference between groups. For the entire cohort, the mean (SD) psychomotor development index score was 77 (20) and the mean mental development index score was 92 (21), with psychomotor development index lower than mental development index both before second-stage surgery (P < .0001) and at 1 year (P < .0001). There were no statistical differences in mental development or psychomotor development scores between the groups at pre-second-stage operation or 1-year follow-up, although the point estimates were consistently lower for the regional cerebral perfusion group.
CONCLUSION: Infant development is delayed after the Norwood operation. Pilot data do not suggest that regional cerebral perfusion improves infant development. Further study with a multicenter clinical trial is imperative to address this important question.

RCT Entities:   Population Interventions Outcomes