Objective To evaluate the safety of gadoterate meglumine injection in routine contrast-enhanced magnetic resonance imaging (MRI) of newborns and infants under 2 years old.Methods It was a prospective, multicenter and non-intervention observational study. A total of 360 newborns and infants under 2 years old who were to receive contrast-enhanced MRI after gadoterate meglumine injection were enrolled from 7 centers in China. Gadoterate meglumine was injected intravenously at the dose of 0.2 mL/kg, and then washed with the same dose of physiological saline. Each child was administered with gadoterate meglumine only once during each contrast-enhance MRI, and the interval between 2 administrations was more than 7 d. The incidence of acute adverse events/reactions was analyzed after gadoterate meglumine injection in newborns and infants under 2 years old.Results The age of the 360 children ranged from 2 d to 24 months, with an average age of (8.20±7.19) months and a median age of 6.00 months. They all received 1 injection of gadoterate meglumine, with an average injection dose of (1.59±0.71) mL. Only 1 child (0.28%, 1/360) had an acute adverse event, presenting as mild vomiting, which was considered to be unrelated to gadoterate meglumine. No measures were taken, and the patient was relieved spontaneously. No treatment-related serious acute adverse events/reactions occurred.Conclusion It is safe for newborns and infants under 2 years old to receive contrast agent gadoterate meglumine injection before contrast-enhanced MRI, and it can be popularized in clinic.