Randomized, controlled trial of amoxicillin prophylaxis for prevention of catheter-related infections in newborn infants with central venous silicone elastomer catheters

Objective: To clarify the effectiveness of amoxicillin prophylaxis in the prevention of catheter-related infections. Method: We performed a randomized, controlled, sequential, prospective trial in newborn infants undergoing percutaneous central venous catheterization. Results: Seventy-five infants (median birth weight, 1240 gm; median age at catheter insertion, 3 days) received prophylactic amoxicillin (100 mg/kg per day); 73 infants in the control group (median birth weight, 1170 gm; median age, 2 days) received no routine prophylactic antibiotic treatment. No infant receiving amoxicillin had septicemia, whereas two infants (2.7%) in the control group did; suspected septicemia (positive clinical and laboratory findings but negative blood culture results) was found in 3 infants in the amoxicillin group and in 6 of the control group (not significant). Bacterial contamination of the catheter tip at removal was significantly reduced in the amoxicillin group (13.3% vs 28.8% in control subjects; p <0.05). Negligible differences were found in duration of catheterization (median, 15 days in both groups), or the number of thrombotic (9.3% vs 2.7% in control subjects) and other catheter-related complications between the groups. Conclusion: A low incidence of catheter-related infections can be achieved in neonates with central venous catheters without using prophylaxis with an antibiotic. (J PEDIATR 1995;127:615-9).