Comparison of two empiric antibiotic regimen in late onset neonatal sepsis--a randomized controlled trial

Abstract

Objective: To compare the effectiveness of two antibiotic regimens among neonates with late onset sepsis (LOS).

Methods: This randomized controlled trial conducted in a tertiary care teaching hospital, South India, included 90 babies with LOS. Detailed history, examination and appropriate investigations were done for all the babies. Cloxacillin + Amikacin were administered to 40 and Cefotaxime + Gentamicin to 50 babies. Outcomes including mortality, complications and treatment failure were evaluated. Chi-square test was used for categorical variables and Student's unpaired t-test for continuous variables.

Results: LOS had a male preponderance, and median time of onset was 13 days. Mortality was more among low birth weight babies irrespective of the antibiotics. Predominant bacteria isolated were coagulase-negative staphylococci (26.67%), Escherichia coli (13.33%) and Streptococcus pneumoniae (13.33%). Complications, mortality and cost were similar in both regimens.

Conclusion: There was no significant difference between the two antibiotic regimens with regard to outcome of LOS.

Keywords: antibiotics; late onset sepsis; neonate.