Ranitidine and late-onset sepsis in the neonatal intensive care unit.

The objective of the study was to examine the effect of ranitidine on the incidence of late onset sepsis. This study was based on information extracted from charts of 569 infants admitted to the neonatal intensive care unit (NICU) from July 2003 to July 2005. All infants admitted for seven or more days were included. Late-onset neonatal sepsis was defined as a positive blood culture with clinical signs of sepsis after seven days of life. Outcome measures included the use of ranitidine, type of infection and infectious agent, birth weight gestational age, and type of care in the NICU. Of the 569 infants admitted, 53 (9.3%) were treated with ranitidine. Of 74 infants who developed late-onset sepsis, 23 infants received ranitidine and 51 did not. Infants receiving ranitidine were at 7-times greater risk of late-onset sepsis (OR 6.99; 95% CI: 3.78-12.94; P<0.0001). The birth weights and gestational ages of infants with sepsis receiving ranitidine and those not receiving ranitidine were comparable, P=0.59. The use of ranitidine in infants admitted to the NICU elevates the risk of late-onset sepsis. The pathological mechanisms need to be further studied. The safety of widespread use of ranitidine in neonates is controversial.