Safety and efficacy of Omniscan (R) (gadodiamide injection) at 0.1 mmol/kgfor MRI in infants younger than 6 months of age - Phase III open multicenter study

RATIONALE AND OBJECTIVES. To demonstrate that gadodiamide injection is a sa fe and efficient contrast agent for MRI in infants younger than 6 months of age. METHODS. The authors designed a phase III multicenter nonrandomized study u sing a control group. Gadodiamide injection at a dosage of 0.1 mmol/kg body weight was administered to 39 children; 20 received no contrast. The mean age was 10.6 weeks in the contrast group and 9.3 weeks in the control group . MR examinations, blood (serum creatinine, S-ASAT, S-ALAT, S-bilirubin, al kaline phosphatase) and urine (proteins, blood, others) sampling before sed ation and after examination, heart rate (electrocardiography) and oxygen sa turation (pulse oximetry) during examination, adverse events, and efficacy parameters were analyzed. RESULTS. In the contrast group, 18 (51.4%) children had 31 abnormal changes in one or more of the safety parameters and vital signs. In the control gr oup there were 16 (80.0%) children with 19 abnormal changes. Gadodiamide in jection had no negative influence on the safety parameters. No serious adve rse events occurred, and only three clinically relevant adverse events (ele vation of S-ALAT and S-ASAT, elevation of bilirubin) in two patients in the contrast group and one event (vomiting) in one patient in the control grou p were documented, The benefit of the contrast medium was clearly shown for all evaluated parameters. CONCLUSIONS. Gadodiamide injection is safe, well tolerated, and effective i n infants younger than 6 months of age.