Role of Semi Quantitative Procalcitonin Test-Kit in Early Detection of Neonatal Sepsis and in Antibiotics use Reduction

Background Clinical signs and laboratory tests of neonatal sepsis are non-specific and diagnosis is difficult. Confirmation of diagnosis needs time. Laboratory tests used to diagnose neonatal sepsis are blood culture, bloodcount, I/T index and CRP which have low sensitivity and specificity. Last year studies show use of procalcitonin (PCT) as early biomarker of infection. Purpose To evaluate and use the effect of procalcitonin (PCT) in diagnosis of neonatal sepsis and PCT-guided decision on duration of antibiotic therapy in suspected neonatal early-onset sepsis. Objectives-Determination of sensitivity and specificity of PCT in the diagnose of neonatal sepsis (SEMI QUANTITATIVE PROCALCITONIN TEST- KIT method) -Negative predictive value of PCT in the diagnosis of neonatal sepsis-Reduction of antibiotic therapy use. Material and Methods This single-center, prospective, randomized intervention study conducted in a tertiary neonatal intensive care unit, janary2012-december 2013, and is still in process. There are included in the study 148 newborns suspected of infection, separated in two groups-PCT group (nr-78) Diagnose based on conventional laboratory parameters and PCT (Antibiotic therapy was discontinued when two consecutive PCT values were below predefined age-adjusted cut-off values (greater than2 ng/ml). -Standard group (n_70) -diagnose based on actual protocols of clinic. This study has evaluated sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) for all laboratory tests used in the diagnose of neonatal sepsis. Results148 newborns were randomly assigned wither to the standard group (n = 70) or the PCT group (n = 78). The two groups were similar for baseline demographics, risk factors for early-onset sepsis, gestational age, birth weight, Apgar score 1 and 5minute, prenatal risk factors and early conventional laboratory findings. PCT show to be more sensitive related to other markers, sensitivity was 90.9 % and NPV 96.15 %. There was a significant difference in the proportion of newborns treated with antibiotics 72 h between the standard group (85.29 %) and the PCT group (59 %) (absolute risk reduction 26.3 %, odds ratio 0.2 (95 % CI 0.07-0.7), p = 0.019). When sepsis ruleout, we found significance difference between two groups in antibiotics use -72h, standart group 80 % vs 45.45 % PCT group ( odds ratio 9.5 (95 % CI 1.7-52). No difference beetwen two groups in GA 34 weeks babies. No difference found in antibiotics treatment in neonates with sepsis in two groups. Clinical outcome was better in study group related to secondary sepsis episode. Conclusion Use of PCT kit test show to be useful in early sepsis diagnosis. Also seem to be useful in shorten the duration of antibiotic therapy in near-term infants with suspected early-onset sepsis, but our data are insufficient, and before this PCT-guided strategy can be recommended in our practice, its safety has to be confirmed in a larger number of neonates.