Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Status:
Completed
Trial end date:
2018-12-19
Target enrollment:
Participant gender:
Summary
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart
surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent
inflammatory response secondary to the body's recognition of the abnormal environment of the
heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney
function after the heart surgery. This is turn can lead to longer times on the ventilator
(breathing machine), the need for higher doses of heart medications, a longer stay in the
intensive care unit and even death. This is particularly true in infants less than one month
of age due to their size and the immaturity of their organs. The appreciation of the
post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions
directed at its reduction. No therapy has been recognized as the standard of care; however
steroid therapy has been applied most often despite unclear evidence of a benefit. This study
aims to determine if steroids improve the outcomes of babies undergoing heart surgery.
Phase:
N/A
Details
Lead Sponsor:
Medical University of South Carolina
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH)