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Abstract Neonatal early-onset sepsis (NEOS) defines as a systemic bacteremia with positive blood–cerebrospinal fluid culture, and life-threatening complications in the first 72 h of neonate’s life. Although the frequency of NEOS is relatively low (0.5–1.2 cases per 1000 live births), its morbidity and mortality rates are high. Several maternal and neonatal causes are involved in the etiology of neonatal sepsis; colonization of organisms in the genitourinary tract, invasive procedures during pregnancy, prolonged rupture of membranes, instrumental delivery, prematurity, low birth weight, neonatal anomalies, and low Apgar scores are some of them. group B Streptococcus, Escherichia coli, and Listeria monocytogenes are also reported as the most frequent pathogens in NEOS. Cytokines including interleukins (IL-2, IL-4, IL-6, IL-10, IL-12, IL-18, IL-23), TNF-α, and IFN-γ are the main members of body immune system. Interleukin 35 (IL-35) as a heterodimer is a member of IL-12 family which is secreted by natural regulatory T cells particularly cluster of differentiation 4(CD4+) and T helper (Th) cells and CD4+ CD25+ regulatory T (Treg) cells. IL-35 has potent anti-inflammatory and immunosuppressive properties in inflammation-related diseases. The former studies have indicated significant alterations of serum IL- 35 levels in patients with primary Sjögren’s syndrome, cancerous diseases, chronic hepatitis, rheumatoid arthritis, encephalomyelitis, Hashimoto’s thyroiditis, and respiratory–cardiovascular disorders. Other studies have also indicated an association between plasma level of cytokines and sepsis; Du et al., )2016) have shown a positive correlation between increase of IL-35 and sepsis severity in both adult and pediatric patients. Summary 98 So, this study aimed to assess the role of the serum interleukin-35 as a diagnostic biomarker of neonatal sepsis and evaluation of its prognostic value in those newborns. To elucidate our aim, this is a case control study was conducted on 90 newborns admitted the NICU of Menoufia university hospital fulfilling inclusion and exclusion after approval of ethical committee and parental consent. The studied newborns were divided into 2 groups: Case group: included 45 newborns meeting the inclusion and exclusion criteria. Control group: included 45 healthy newborns matching the case group in gestational age and birth weight. All newborns will be subjected to: Full history including: Prenatal history, Maternal history include: DM, HTN, PROM (Premature rupture of membrane) and date of the last menstrual period, Perinatal history include: History of obstructed labor and APGAR scores. Natal history: (llness seizures, respiratory distress, hyperbilirubinemia, metabolic disorder, Malformations). Clinical examination classficate to: General: (Birth weight, Head circumference, …etc), Systemic: (Chest, Cardiac, Abdominal, …etc). Laboratory Investigations: complete blood count (CBC), at admission and after 72 hours, arterial blood gas, serum electrolytes (Na,K), liver and kidney functions (Urea, ceratinine, ALT, AST), CRP and blood culture and assay of serum interleukin-35 at clinical or hematological suspicion of sepsis using Enzyme-Linked Immunosorbent Assay (ELISA) kits. Results of the current study could be summarized as follows: There were no significant differences among studied groups regarding gender, age, gestational age and maternal age (p>0.05). While, birth weight and current weight were significantly decreased among the cases group than the control group (p<0.05). Cesarean section was Summary 99 significantly higher among the cases group than the control group (p=0.002). There were no significant differences among studied groups regarding diabetic militias, hypertension and urinary tract infection (p>0.05). While, premature rupture of membranes was significantly higher among cases group than control group (p<0.05). Respiratory rate and mean blood pressure were significantly higher among cases group than control group (p<0.05). While, there was no significant difference among studied groups regarding heart rate and temperature (p>0.05). Clinical and hematological sepsis scores were significantly higher at admission than after 72 hours in cases group (p<0.05). Hemoglobin, white blood cells, hematocrit % and immature / total neutrophil ratio were significant lower after 72 hours compared at admission in cases group (p<0.05). While, there were no significant differences at admission and After 72 hours in cases group regarding platelet and C-reactive protein (p>0.05). The predominate organism was Klebsiella representing most of the gram -ve infection follow by gram +ve as the predominate gram +ve infection. Serum interleukin-35 was significantly higher among Cases group than Control group (p<0.05). Serum Interleukin-35 was higher in non-survived group however this deference was not significant (P=0.283). also, there were no significant difference among gestational age ≤37 and gestational age >37 studied groups regarding serum Interleukin-35 (P=0.711). There was significant positive correlation between Serum IL 35 and WBCs after 72 hours (p=0.041). Summary 100 ROC curve analysis showed that serum interleukin-35 to discriminate Cases it had sensitivity of 100%, specificity of 100% at AUC of 1.00 with cut off value >110 |