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06.01.2016 | Original Article

Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis - A Randomized Controlled Trial

verfasst von: B. Vishnu Bhat, P. Prasad, Venkata Banda Ravi Kumar, B. N. Harish, K. Krishnakumari, Anand Rekha, G. Manjunath, B. Adhisivam, B. Shruthi

Erschienen in: Indian Journal of Pediatrics | Ausgabe 5/2016

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Abstract

Objective

To compare the clinical outcome of a multiplex polymerase chain reaction (PCR) based molecular diagnostic method -- Syndrome Evaluation System (SES) directed treatment strategy vs. standard of care (blood culture) directed treatment strategy for neonatal sepsis.

Methods

This randomized controlled trial (RCT) included 385 neonates with sepsis who were randomized into two groups -- SES and control (BACTEC). Both tests were performed for all the neonates. However, in the SES group, the results of SES test were revealed to the treating clinicians, while in the control group, SES results were withheld. Two ml of blood was drawn from each baby. One aliquot was sent for blood culture, whereas the remaining aliquot was sent for SES. Babies were then administered empirical IV antibiotics and given supportive care. Further antibiotic changes, if required were done in SES and control groups based on their respective reports. The microbiological profile, immediate outcome, duration of hospital stay, number of antibiotics used and readmission within a month in both groups were compared.

Results

SES was better than BACTEC in identifying the causative organism in both the groups (68 % vs. 18 % in SES group and 72 % vs. 18 % in control group). SES had 100 % concordance with blood culture by BACTEC. Detection of bacteria and fungi were four and ten-fold higher respectively with SES when compared to BACTEC culture. Microbiological diagnosis was rapid with SES compared to BACTEC (7 h vs. 72 h). Treatment based on SES resulted in significantly less mortality (3 % vs. 18 %). Readmission rate, duration of hospital stay and change in antibiotics were also significantly less in SES group.

Conclusions

This new molecular based diagnostic system (SES) helps in rapid and accurate diagnosis of neonatal sepsis and reduces mortality and morbidity in affected neonates.

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Titel: Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis - A Randomized Controlled Trial
verfasst von: B. Vishnu Bhat
P. Prasad
Venkata Banda Ravi Kumar
B. N. Harish
K. Krishnakumari
Anand Rekha
G. Manjunath
B. Adhisivam
B. Shruthi
Publikationsdatum: 06.01.2016
Verlag: Springer India
Erschienen in: Indian Journal of Pediatrics / Ausgabe 5/2016
Print ISSN: 0019-5456
Elektronische ISSN: 0973-7693
DOI: https://doi.org/10.1007/s12098-015-1956-3

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Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis - A Randomized Controlled Trial