Steroids to Assist in Recovery from Heart Surgery: The STRESS Trial – Phase III

STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)

Protocol Description

This multi-center study evaluates the effects of methylprednisolone in infants undergoing cardiopulmonary bypass surgery with a goal of determining the optimal dosing level. Methylprednisolone is an anti-inflammatory steroid. Researchers believe that it may help decrease post-operative inflammation and, in so doing, decrease a child’s risk of serious complications including liver, kidney, or respiratory failure.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, infants up to 12 months of age who were born with a heart defect that requires surgery with cardiopulmonary bypass are eligible to participate.
Boys and Girls: Up to 12 months of age


Participants will be randomly assigned to receive either the study drug or a placebo at the time of surgery. . After the surgery is completed, each participant will undergo routine post-operative care, with researchers monitoring and recording details about his or her recovery.
Visits: None beyond standard care
Duration: Same as standard care for the surgical procedure

Status: Open to Enrollment

Source(s) of Support

National Institutes of Health

Primary Investigator

Brian Blasiole, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Denise McCarthy RN, BSN, CRC