Objective:To evaluate the safety and efficacy of a dedicated neonatal-infant brain 0.35 T MRI system.Methods:A dual-center controlled clinical trial was conducted with single-arm objective performance criteria. From June to July 2020, sixty-six infants aged 0-12 (6.3±3.4) months were recruited from Children′s Hospital of Soochow University and the First People′s Hospital of Lianyungang prospectively. All infants underwent brain MRI with a dedicated neonatal-infant 0.35 T brain MRI system, using the dedicated two-channel transceiver head coil. MRI protocol included spin echo T 1WI, fast spin echo T 2WI, fluid attenuated inversion recovery, diffusion weighted imaging and 3D gradient echo sequence. MRI sequences were set with three orientations (axial, sagittal and coronal). Each case received at least two scanning planes and two scanning sequences. Five-point Likert scoring system was used to evaluate the image quality of acquired images, and the target value was set as at least 3 points per image. The temperature, heart rate and breathe of the infants were recorded before and after MRI; the acoustic noise of the MRI system was measured during the scanning process; and the adverse reactions were recorded if presented. Results:Five infants successfully completed their examination during non-sedated sleep in a single attempt, and 61 infants after sedation with chloral hydrate. Based on MRI-based five-point Likert scoring system, 41 cases achieved a score of 5, 21 cases with a score of 4 and 4 cases with a score of 3. Cases with score of 3 was due to movement of the infants during the scan, which resulted in motion related artifacts. The vital signs of all infants showed stable before and after imaging, with heart rate of (126.8±12.9) beats per minute, breathe of (38.2±6.8) times per minute. It was found that 47 cases showed no sign of temperature raise after brain MRI, 15 cases had less than 0.3 ℃ raise and 4 cases had 0.3 ℃ to 0.5 ℃ raise. The noise recorded during the scanning process was (57.5±1.8) dB(A). One case had mild diarrhea on the day of MR scan, and the symptoms disappeared on the second day without treatment; no adverse reactions were found for the rest subjects.Conclusion:Dedicated neonatal-infant 0.35 T brain MRI system allows data acquisition with high safety and excellent image quality, which has potentials in the clinical applications.