Gadolinium is a toxic rare earth element that is used as a contrast enhancement agent for diagnostic medical imaging. However, because of safety concerns to the developing fetus derived from preclinical studies, gadolinium can only be used during pregnancy if the potential benefits justify the potential risks to a fetus. Since there are no previous well designed safety studies on the developing fetus, we aimed to evaluate the potential adverse effects of in utero gadolinium exposure in high-risk premature infants. We performed a prospective dose (cord blood gadolinium concentration) – response (outcomes) study involving 104, 24-33 weeks gestational age infants. The mean (range) cord blood gadolinium concentration of infants measured using Inductively Coupled Plasma Mass Spectrometry was 191 (3.4 - 3729.6) pg/mL. The association between cord blood gadolinium concentration and each neonatal outcome was evaluated using linear or logistic regression analysis. The gestational age, race, gender, and antenatal steroid exposure were considered priori confounders. Recent adult human studies have shown that gadolinium exposure may be associated with nephrotoxicity. However, we found no adverse effects on renal function or other common outcomes including degree of prematurity, small for gestational age, respiratory distress syndrome, hyperbilirubinemia, intraventricular hemorrhage, necrotizing enterocolitis, patent ductus arteriosus, chronic lung disease, retinopathy of prematurity and osteopenia of prematurity during the neonatal period with an increase in cord blood gadolinium concentration. None of the infants had clinically evident congenital malformations. In conclusion, gadolinium use during pregnancy is unlikely to be associated with adverse effects in infants during the neonatal period.

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