We investigated the changes in the serum leptin concentration from birth to 30 days of age in order to determine the effects of leptin in early infancy. Twenty-seven Japanese term infants (12 boys and 15 girls) were examined. The serum leptin concentration at 3-6 days of age was significantly lower than that in cord blood (p < 0.0001) and was significantly higher at 30 days than at 3-6 days (p < 0.0001). The serum leptin concentration did not differ with gender or nutrition. The body weight gain and the magnitude of leptin rise that occurred between 3-6 and 30 days of age showed a significant positive correlation (r = 0.79; p < 0.0001). These changes in leptin levels suggest that leptin plays an important role in the regulation of weight gain in early infancy.