Abstract
Background: There are several studies regarding perforations after intravenous immunoglobulin (IVIG) infusion; however, the risk factors are not defined yet. Objectives: The present study aimed to investigate gastrointestinal complications in newborns regarding the reported immunoglobulin A (IgA) levels in IVIG preparations. Methods: This retrospective chart review was conducted on term newborns who received IVIG therapy in two centers in Istanbul. The study included patients with IVIG-associated gastrointestinal bleedings, necrotizing enterocolitis (NEC), and intra-abdominal perforations without any underlying diseases and recorded demographic data (gestational age, birth weight, and gender) and the IgA levels in the IVIG preparations. Infants born below 35 gestational weeks were excluded as they were more likely to have NEC. Results: A total of 71 patients received IVIG therapy, and 15.5% (n = 11) developed major gastrointestinal system (GIS) complications. A total of 36 patients were born ≥ 35 gestational weeks, and gastrointestinal perforation or bleeding occurred in 22.2% (n = 8) of these patients. Two patients died before surgery due to aggressive disease progression. None of these patients had any gastrointestinal symptoms before IVIG therapy or any predisposing factors for gastrointestinal perforation. All patients were on spontaneous breathing and enteral feeding without intolerance. The IgA level content of the IVIG preparations was related to the major GIS complications with strong evidence, and the safe threshold resulted in 14 mg/dL in receiver operating characteristic (ROC) analysis in the present study group. Conclusions: Higher IgA levels in IVIG preparations might be a risk factor for gastrointestinal perforation and bleeding in term newborns. Clinicians should be aware of this potential complication when using IVIG therapy in term newborns and closely monitor for signs and symptoms of major gastrointestinal complications.