Post-bypass Prophylactic IVIG in Infants and Neonates

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Grifols Biologicals Inc.; Grifols Biologicals, LLC
• Treatments: Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• Infants <6 months old

• Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

• 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