| Objective: Throughout the world, 1.6 million newborn infants die every year from infectious diseases. Although most of these deaths are in developing countries, where mortality form neonatal sepsis may be as high as 60%, the incidence of neonatal infectious diseases in the developed world is also high at 2.2-8.6 per 1000 live births. The mortality form severe sepsis in newborn infants remains high at between 20% and 40% over the last 2-3 decades despite the use of broad spectrum antibiotics and supportive care. Early accurate diagnosis and treatment help to improve prognosis of neonatal sepsis. The diagnosis of sepsis is challenging due to the nonspecific nature of clinical presentation, the variety of other neonatal disorders within the differential diagnostic workup, and the lack of sensitivity and specificity of available diagnostic procedures. In recent years, the search for diagnostic tests of neonatal sepsis has turned to some cytokines as well as to other substances associated with the inflammatory response. However, these tests are at the research stage and not universal in clinical application. The present research pays great attention to the many parameter reasonable applications and the generalized analysis, providing empirical physiologic data that permit pediatricians to make a diagnosis of sepsis at the bedside by using predictive clinical variables and highly sensitive and specific laboratory tests.The objective of this study is to compare the diagnostic values of different parameter for neonatal sepsis, by observing clinical presentation and laboratory tests of hospitalized newborn infants ,so that how to optimize pediatricians to comprehensive utilization of clinical and laboratory data for early and accurate diagnosis of neonatal sepsis .Methods: The newborn infants hospitalized in NICU from September 2007 to February 2008 met all inclusion and exclusion criteria were enrolled in the study and observed clinical presentation and laboratory tests. Infants were classified as septic group(n=13),nonseptic group (n=12 ),noninfectious group (n=12) .The situations in perinatal period, occurring time of infection, clinical manifestations and laboratory indexes were recorded in detail. Sensitivity, specificity, false positive rate, false negative rate, Youden's index ,and positive and negative predictive values (PPV and NPV) were calculated for each test. Receiver-operating characteristic curves were analyzed to determine the optimal thresholds.Results: Comparing the optimum variables for neonatal sepsis showed that: 1. abnormal reaction of clinical manifestations had the hightest specificity(84.6%), corresponding the lowest false negative rate.2. SIRS criteria (Specificity= 95.8%)was objective, economical and prompt and helpful to diagnosis for infants with sepsis suspected on clinical grounds .3. Routine laboratory tests such as WBC, PLT ,GLU had poorl sensitivity or specificity ;I/T has a better specificity, but also was subject to considerable interobserver variation. A combination of WBC and I/T provided a better diagnosis value.4.Area under the ROC curve was 0.734 for CRP, optimal threshold was 15mg/L(P=0.020,Youden's index = 45.5%), better than 8mg/L.5. Area under the ROC curve was 0.878 for PCT, optimal threshold was 0.81ng/ml (P=0.000, specificity =100%, Youden's index=75.0%).Conclusion: The careful clinical observation and attention can effectively found these sick infants. Evaluation of SIRS criteria for infants with suspected sepsis is objective, economical , prompt and specific for early identification. WBC,I/T,PLT can be used as routinely monitoring indexes for the high risk neonates. CRP and PCT concentrations showed a significantly prompt diagnostic value, especially PCT. Before the blood culture result coming back, multivariate analysis of clinical manifestations and laboratory tests permit pediatricians to get the greatest predictive value at the bedside.
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