Post-bypass Prophylactic IVIG in Infants and Neonates
Hypogammaglobulinemia, Congenital Heart Disease
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About this trial
This is an interventional treatment trial for Hypogammaglobulinemia focused on measuring congenital heart disease, Cardiopulmonary Bypass, Hypogammaglobulinemia
Eligibility 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
Sites / Locations
- Children's of Alabama
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IVIG
Normal Saline
Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration.
Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy.