Gd-DOTA administration at MRI in children younger than 18 months of age: immediate adverse reactions.

Background: There is a paucity of evidence with regard to the safety of contrast medium administration at MRI in neonates and infants.

Purpose: To assess immediate adverse reactions in children younger than 18 months of age during routine clinical utilization of gadoteric acid (Gd-DOTA) in a cohort of patients with nonselected indications.

Materials And Methods: One hundred and four neonates and infants were enrolled in a postmarketing survey with Gd-DOTA (Dotarem, Guerbet, Roissy, France) from a single pediatric hospital. A standardized questionnaire was used to collect the patient information.

Results: All included children, ages 3 days to 18 months, received one injection of Gd-DOTA (volume 0.6-4 ml). No immediate adverse event was reported.

Conclusion: This postmarketing study involving neonates and infants suggests a favorable safety profile of Gd-DOTA in routine practice.