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Indian Pediatr 2011;48: 657-658

Short course of Antibiotics in Neonatal Sepsis

It is appreciable effort on part of Saini, et al. [1], 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 [2]. 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 also.

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 pilot study.


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,
MMIMSR, Mullana,
Ambala, Haryana,
E-mail: b_maini@rediffmail.com



The diagnosis of neonatal sepsis using a "sepsis screen" is not as simple as it sounds. Two systematic reviews have concluded that although none of the standard sepsis screen parameters (or combinations thereof) is satisfactory, CRP is the best individual parameter. It is for this reason that we opted for CRP alone. CRP is widely accepted and used and the objection about it’s "high cost" is an individual viewpoint. It is true that fresh cases of culture-negative sepsis may get incorrectly included as "treatment failure" and may not necessarily get evenly distributed despite randomization. This is an unavoidable risk in a pilot trial. We have not concluded that a shorter duration of antibiotics should become a standard of care. We have only suggested that on the basis of this small study, a large definitive non-inferiority trial could be planned.

Sourabh Dutta and Shiv Sajan Saini

Email: sourabhdutta@yahoo.co.in


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