Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

1. Neonate (< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair

2. Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

1. requirement for extracorporeal membrane oxygenation (ECMO) in the operating room

2. Known immune deficiency

3. Having previously received systemic steroids (except for two routine preoperative doses)

4. A current signed Do not resuscitate (DNR) or limitation of care order

5. Current enrollment in another interventional clinical study

6. Refusal of parental consent

7. Previous diagnosis of adrenal insufficiency

8. > 28 days old at time of surgery whose repair dose not require CPB