It is appreciable effort on part of Saini, et al. , to cut short
the usage of antibiotics in case of culture negative "sepsis" but we have
some observations regarding the study.
A complete sepsis screen score should have been taken
into consideration before deciding to start the antibiotics. CRP alone
with clinical suspicion will lead to falsely high number of neonates
getting enrolled which will affect the primary outcome as these ‘false
positive’ cases are less likely to present with’ treatment failure .
Sepsis score not relying upon ‘CRP alone’ would have been more useful as
this costly test is not universally available, as mentioned by the authors
Babies falling sick within fifteen day period are
presumed to be the continuum of initial episode while a re-infection or
sepsis caused by different organism cannot be ruled out completely. The
number of neonates who were labeled as ‘treatment failure’ will be
inflated falsely because of re-infection/fresh sepsis. It is not possible
to ensure equal distribution of these fresh cases in both groups as sample
size is very small. So the conclusion drawn that the short course
antibiotics is not harmful can not be validated adequately even by this
1. Saini SS, Dutta S, Ray P. Short course versus 7 day
course of intravenous antibiotics in probable neonatal septicemia. A pilot
open label randomized controlled trial. Indian Pediatr. 2011;48:19-24.
2. Edwards MS. Immune system (part2) –postnatal
bacterial infections. In: Martin RJ, Fanaroff AA, Walsh MC
(editors). Fanaroff and Martin’s Neonatal and Perinatal Medicine-Diseases
of Fetus and Infant. 8th ed. Philadelphia: Elsevier Mosby; 2006.p.798.
Baljeet Maini and Vipul Gupta,