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).