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

Completed · Not applicable

Conditions studied: Heart Disease Congenital Complex

In brief

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.

Key facts

Study ID

NCT01595386

Run by

University of Alabama at Birmingham

People needed

40

Starts

2012-04-01

Expected to finish

2013-11-01

Last updated by the study team

2015-11-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Successfully weaned off cardiopulmonary bypass after cardiac surgery

You may not qualify if…

• requirement for extracorporeal membrane oxygenation (ECMO) in the operating room
• Known immune deficiency
• Having previously received systemic steroids (except for two routine preoperative doses)
• A current signed Do not resuscitate (DNR) or limitation of care order
• Current enrollment in another interventional clinical study
• Refusal of parental consent
• Previous diagnosis of adrenal insufficiency
• > 28 days old at time of surgery whose repair dose not require CPB

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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