Background & Aims: Sepsis is the principal cause of death in the first months of life and leads to 30- 50% of infant mortality in developing countries (1). The prevalence of sepsis is reported differently in many countries. In developed countries, the prevalence of sepsis is 1-4 per 1,000 live births, while in poor and developing countries it is almost ten times higher (2). Neonatal sepsis leads to 25.2% of all neonatal deaths in Iran (3). The clinical signs of neonatal sepsis are nonspecific and may be mixed with noninfectious disorders such as aspiration syndrome and respiratory distress syndrome (4,5). The most important factor in reducing infant mortality from sepsis is appropriate and quick treatment (6). On the other hand, the clinical signs of affected infants, including decreased neonatal reflexes, bradycardia, hypo/hyperthermia, respiratory distress, seizures, weakness and lethargy, apnea, and abdominal distension, are not sensitive enough to definitively diagnose sepsis. Blood tests and immunological tests also have less sensitive and specific compared to blood culture (7). Since sepsis is one of the most important causes of mortality and disability in the neonatal stage, with early diagnosis and treatment of the disease and improving the quality of care during delivery, neonatal survival can be increased, the clinical signs, predisposing factors, laboratory findings, treatment and outcome of neonates with the diagnosis of sepsis who admitted to Afzalipour hospital in Kerman were evaluated. Methods: This was a descriptive and cross-sectional study. The statistical population was all infants admitted to Afzalipour Hospital in Kerman from 2015 to 2017.The sample size was determined with the census method (sample size = 200 infants). Infants with Complete Blood Count (CBC), arterial gas measurement, C Reactive Protein (CRP), blood and urine cultures, and Cerebrospinal fluid (CSF) were included in the present study. All neonates with a diagnosis other than sepsis were excluded from the study. Based on clinical and laboratory findings, neonates were classified into three groups: 1- Infants who had positive blood culture sepsis in addition to clinical and laboratory findings. 2- Neonates who had only laboratory and clinical findings of sepsis but their blood culture was negative. 3- Infants who had clinical signs of sepsis but were negative for laboratory findings and blood culture. All infants were treated with antibiotics immediately after the tests. Clinical and laboratory findings as well as the type of antibiotic and maternal and neonatal risk factors were collected using a checklist. Outcomes of treatment were expressed as improvement and discharge, complications, and death. The collected data were analyzed using SPSS software version 25 (version 25, SPSS Inc., Chicago, IL). Quantitative data were presented as Mean ± SD (standard deviation) and frequency and percentage. Results: The highest age of infants was related to the birth group (91%). 59.5% of infants were male and 40.5% were female. The mean duration of admission was 9.76. 1.05 days. The most common clinical signs were tachypnea (74%), poor nutrition (36%), apnea (32%), and hypo/hyperthermia (25%) respectively. The results showed that 91.5% of participants used ampicillin, 93% of them gentamicin, 84% of them used vancomycin, 52% of them used meropenem, 18.5% of them used metronidazole, 19.5% of them used amikacin, 18 % of them took cefotaxime, 19% of them used fluconazole, 1% of them used clindamycin and 1.5% of them used ceftazidime Regarding the frequency distribution of risk factors, the results showed that 23.5% of participants had PROM (Premature rupture of Membrane), 11 % had maternal urinary tract infection, 12 % had maternal fever and 91.5% had low birth weight. The results showed that the mortality rate for participants was 78% and the rate of discharge and recovery was 22%. The results showed that the mean number of white blood cells was 16.468 ± 0.103 × و 103 and the mean CRP of the participants was 22.6 ± 2.8. The results of this study also showed that 14.5% of participants had positive blood cultures and 85.5% of them had negative blood cultures. Conclusion: Systemic and local infections are very common in infants. Sepsis is a systemic response to infection and is divided into early, late and nosocomial types (17). The results showed that 59.5% of the participants who had early sepsis were male and 40.5% of them were female, which is consistent with the results of Khalili et al. (13). While in the textbooks, the incidence of male infants is twice as high as female infants (18). In the study of Arab Mohammadi et al., 60% of patients were boys and 40% were girls. In this study, the most common clinical symptoms were tachypnea (74%), hypo/hyperthermia (25%), and tachycardia (5%), respectively, which is consistent with the results of Hengst et al. (10) while it is not similar to the results of Khalili et al. (13), Santana et al. (9) and Vergnano et al. (14). In other textbooks, the most common clinical symptoms are fever, jaundice, respiratory distress, hepatomegaly, anorexia, vomiting, and cyanosis (19). In the study of Shiva et al. (20), a total of three symptoms of tachycardia, tachypnea, hypothermia had a sensitivity of 53.6% and a specificity of 100% in identifying sepsis with positive blood culture. In the study of Arab Mohammadi et al. (21), hyperthermia, jaundice, respiratory distress, hepatomegaly, anorexia, vomiting, lethargy, and cyanosis were reported as the most common symptoms of sepsis. Investigation of 500 infants suspected of sepsis, temperature instability, and respiratory symptoms were the most common symptoms. The results showed that 14.5% of the participants had positive blood cultures and 85.5% of them had negative blood cultures. This rate (positive blood culture) was 15.4% for the study of Khan et al (22). This rate was 14% in the study of Manucha et al. (23) in India. The reason for the lack of positive blood culture is neonatal SEPSIS is one of the diseases in which the actual number of cases is much less than the number of suspected cases and laboratory-related problems also play an important role in this results (24). The prevalence of sepsis with positive blood culture has been reported in the study of Shiva et al. 25% (20), Samaei et al. 41% (25), and Hosseini et al. The results showed that the mean CRP of the participants in our study was 22.6. 2.8. According to textbooks, if CRP is performed in combination with other tests, it is effective in screening for sepsis, but if used alone as a primary test to look for infection, it helps in less than 10% of definite diagnoses (26, 27). CRP sensitivity has been reported from 46 to 74% in various studies (28). In the meta-analyzes about this subject, the first time CRP sensitivity was 39%, CPR specificity was 92.5%, positive predictive value was 53.2% and negative predictive value was 93.6%. Therefore, it seems that the serum level of CRP for the first time at the time of admission in infants suspected of early neonatal sepsis in the neonatal intensive care unit (NICU) has no value in determining sensitivity (29). In the study by Zecca et al, the negative predictive value of CRP was 100% (30 %). A study by Cetinkaya et al on 100 infants suspected of having early neonatal sepsis showed that the diagnostic power of CRP increased over time and peaked 24 to 48 hours after the onset of sepsis, which is consistent with our study (31). Therefore, if serum CRP levels remain negative 24 hours after the onset of clinical symptoms, the high negative predictive value is 99%, and antibiotic therapy can be discontinued in the absence of strong clinical suspicion of sepsis (32). [ABSTRACT FROM AUTHOR]