3 days vs. 7 days course of intravenous antibiotics for probable neonatal sepsis

Abstract

Introduction: Duration of appropriate antibiotic therapy for neonatal sepsis does not have evidence-based guidelines. The rationale and safety of these recommendations have never been scientifically evaluated. Such untested approaches could result in the unnecessary use of antibiotics leading to increased cost of care, unneeded intravenous cannulation, prolonged hospitalization, mother-infant separation, increased colonization by pathogenic organisms and emergence of drug resistant strains. So, our objective was to compare 3 days v/s. 7 days course of intravenous antibiotics for probable neonatal sepsis in order to determine the optimal length of antibiotic therapy so that infants with genuine infection would be adequately treated while those without infection would not be over-treated. Methods: Randomized controlled trial (computerized randomization) done in the Neonatal Intensive Care Unit in a Tertiary care Teaching Hospital, Mysuru. About 150 neonates who were admitted in NICU for probable sepsis (clinical signs of sepsis and positive septic screening), who were on antibiotic therapy, with sterile blood culture at 3rd day of admission were the participants. Neonates who fulfilled the inclusion criteria were randomly divided into two groups, i.e; those who received 3 days of antibiotics and those who received 7 day course of antibiotics. Successful therapeutic outcome was measured in terms of weight gain, no apparent signs of sepsis as ascertained by clinical examination & no re hospitalization for sepsis. Results: Among the 150 eligible neonates in the study, (75 each in Groups 1 and 2, which were comparable with regard to term/preterm population and also early and late onset neonatal sepsis), there was no statistically significant difference in the outcome between the two groups in terms of mean age at presentation, gestational age, mode of delivery, age of onset of sepsis at presentation and relapse rates. However, the duration of hospital stay in group 1 babies who received 3 days of antibiotics was significantly shorter than in group 2 babies who received 7 days of antibiotics. Conclusion: 3 day course of antibiotics is enough for culture sterile probable sepsis, in both term and preterm babies and also in both early and late onset neonatal sepsis.