A Pilot Randomized Control Trial of Safety and Feasibility of a Delayed Rewarming Intervention for Infants Following Cardiopulmonary Bypass Surgery

Abstract

Objective: Investigate safety and feasibility of a 12-hour delayed rewarming intervention on infants following congenital heart disease (CHD) surgery. Study Design: Pilot randomized control trial of infants <6 months old with CHD undergoing cardiopulmonary bypass surgery. Infants were randomized 1:1 to standard of care (SOC) or to delayed rewarming intervention, accomplished by using a commercially available temperature regulating blanket set to gradually rewarm from 35°C to 36.5°C in the 12-hours following surgery. Safety was assessed by comparing the frequency of severe adverse events (SAE) for 48 hours after surgery. Feasibility was assessed by analysis of temperature data. Results: Twelve infants were randomized to SOC and 10 to the intervention group. Eight infants (36%) were female, 6 (27%) had Trisomy 21 and 7 (32%) had surgery in the first two weeks of life. Two SOC and one intervention infant had at least one SAE (p=0.57). Feasibility of the delayed rewarming intervention was demonstrated by a statistically significant difference in temperature over time between groups (p<0.001). Heart rates for infants in the intervention group were slower during and after the intervention, without significant changes in blood pressure. Infants in the intervention group had no evidence of coagulopathy with lower, but not statistically significantly lower, chest tube output at alltime points. Conclusions: There were no differences in the number of SAEs for the delayed rewarming group and the temperature curve indicates that the intervention is feasible. The results of this small study, from a single, small volume center must be interpreted cautiously. (NCT03036072).