Post-bypass Prophylactic IVIG in Infants and Neonates

Completed · Not applicable · Has a placebo group

Conditions studied: Hypogammaglobulinemia, Congenital Heart Disease

In brief

The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).

Key facts

Study ID

NCT02043379

Run by

University of Alabama at Birmingham

People needed

50

Starts

2014-05-01

Expected to finish

2015-06-01

Last updated by the study team

2017-04-13

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants <6 months old
• Successfully weaned off cardiopulmonary bypass after cardiac surgery

You may not qualify if…

• Requirement of extra corporeal membrane oxygenation in the operating room
• Known immune deficiency
• Current Do Not Resuscitate or limitation of care order
• Current enrollment in another interventional clinical study
• Refusal of parental consent

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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