Clinical Research Directory

Inclusion Criteria: * Infant under 120 days old with established diagnosis of BA. Subjects in this trial must start treatment within 3-5 days of the Kasai procedure and be part of a prospective study of the natural history of biliary atresia also being conducted by ChiLDREN (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3). * Standard HPE operation has been performed for BA within the previous 3 days * Post-conception age ≥ 36 weeks at time of enrollment * Weight at enrolment ≥ 2000 gm * Written informed consent to participate in the study obtained within 3 days of completion of HPE. Exclusion Criteria: * Laparoscopic HPE or "gall bladder Kasai" (cholecysto-portostomy) surgery was performed * Biliary atresia splenic malformation syndrome (presence of asplenia, polysplenia or double spleen) * History of a hypercoagulable disorder * Renal Disease defined as serum creatinine \> 1.0 mg/dl prior to enrollment or presence of complex renal anomalies found on imaging * Evidence of congestive heart failure or fluid overload * Presence of significant systemic hypertension for age (defined as persistent systolic blood pressure ≥112 mmHg measured on at least 3 occasions following HPE) * Infants whose mother is known to have human immunodeficiency virus infection * Infants whose mother is known to be serum HBsAg or hepatitis C virus antibody positive * Previous treatment with intravenous immunoglobulin therapy or corticosteroid therapy * Previous treatment with any other investigational agent * History of allergic reaction to any human blood product infusion * Infants with other severe concurrent illnesses, such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders, that would interfere with the conduct and results of the study * Any other clinical condition that is a contraindication to the use of IVIG