Intrapartum prophylaxis with ceftriaxone decreases rates of bacterial colonization and early-onset infection in newborns

Because of high rates of neonatal gram-negative sepsis in many Latin American countries, we prospectively enrolled 784 high-risk pregnant women in a study designed to evaluate the effect of a single 1-g dose of ceftriaxone (n = 390) vs. that of no antibiotic prophylaxis (n = 394) on oral, rectal, and umbilical colonization and fatality rates among newborn infants. The mean ceftriaxone concentration in cord blood samples was 26 μg/mL (range, 9–40 μg/mL). Compared with infants of untreated mothers, children born to women who were given ceftriaxone were colonized at a lesser rate by gram-negative bacilli (54% vs. 35%; P <.001) and by group B streptococci (54% vs. 21%; P =.03) and endured significantly fewer sepsis-like illnesses in the first 5 days of life (8.1% vs. 3.1%; P =.004). There was also a tendency for them to have fewer episodes of culture-proven early-onset sepsis (2.8% vs. 0.5%; P =.06). Sepsis-related case-fatality rates (0.8% and 0.3%, respectively) were not significantly different. Although intrapartum administration of a single dose of ceftriaxone to high-risk mothers could be a safe and potentially useful strategy for reducing early-onset neonatal infections, additional information is required before this approach can be recommended for routine prophylaxis.