Randomized trial using piperacillin versus ampicillin and amikacin for treatment of premature neonates with risk factors for sepsis.

Premature infants with risk factors for early onset sepsis who were less than seven days of age were blindly randomized to receive either piperacillin and placebo (200 infants) or ampicillin and amikacin (196 infants). One of 30 treated infants developed positive blood cultures. The overall mortality in the two groups was 8.5% for piperacillin/placebo and 13.8% for ampicillin/amikacin (p = 0.11). Serum creatinine elevation above 100 mumol/l (1.131 mg/dl) during treatment was similar in the two groups. The effectiveness of piperacillin/placebo is similar to that of ampicillin/amikacin for empiric treatment of premature newborns with risk factors for early onset sepsis.