Routine antibiotic use in preterm neonates: a randomised controlled trial.

The immature immune system of preterm neonates puts them at higher risk of neonatal sepsis. We conducted a part-blinded randomised controlled trial to compare the effect of routine antibiotic treatment on the incidence of clinical sepsis in preterm neonates. Preterm neonates without other risk factors for infection admitted in the first 12h of life were randomised to receive routine antibiotics or to a control group (no antibiotics unless clinically indicated). The primary outcome variable was the incidence of clinical sepsis. Secondary outcomes were the incidence of positive blood cultures, necrotising enterocolitis (NEC) stage II or III, or death, and the duration of hospital stay. The incidence of clinical sepsis was comparable in both groups (intervention 31.9%, control 25.4%; P=0.392). Mortality was equivalent in both groups. The control group had significantly more positive blood cultures (P=0.002). The incidence of NEC and the duration of hospital stay were comparable in both groups. In low risk preterm neonates we found no evidence that routine antibiotic use has a protective effect.