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临床试验/NCT03880305
NCT03880305Unknown不适用

White Blood Cells and Platelets Indices as a Prognostic Factor in Neonatal Sepsis

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
white blood cells indices

研究概览

简要总结

Sepsis is a complex condition initiated by a pathogen and mediated by cytokines followed by immune, inflammatory, and coagulation homeostasis disturbances, its evolution being dictated by a complicated balance between pro inflammatory and anti- inflammatory factors. Most of the short and long-term complications of the neonatal sepsis are strictly related to inflammatory mediators. Neonatal sepsis is associated with a mortality rate that ranges from 13 to 60% inspite of improved antibiotic therapy and an increased morbidity in survivors .

详细描述

"Suspected sepsis" is one of the most frequently encountered diagnosis in neonatology because: a) a large number of newborns are evaluated for early or late sepsis based on risk factors and for fear of missing a correct diagnosis and a prompt treatment ; b) in neonates, the clinical signs of infection are not specific, late, and the differential diagnosis with neonatal respiratory distress syndrome, aspiration syndromes or neonatal maladaptation to extra-uterine life is difficult ; c) blood culture - the golden standard in neonatal sepsis diagnosis - provides late information, has a poor accuracy, and is not universally available; and d) up to date, there is no an ideal diagnostic tool for neonatal infection . Therefore, diagnosis of neonatal sepsis is still a challenge for neonatal medicine.

Antibiotic therapy is often initiated based upon clinical suspicion and/or the presence of risk factors, leading to excessive antibiotic therapy. Very often the diagnosis criteria for neonatal sepsis consists in documenting an infection in a newborn with severe systemic disease in which all possible noninfectious explanations for the patient's altered physiological status are either ruled out or unlikely.

The "gold standard", definitive test for neonatal sepsis is the isolation of the pathogen from blood. However, its accuracy is influenced by multiple factors a) contamination during sampling; b) sampling after antibiotic therapy was started; c) insufficient sampling volume; d) low colony count bacteremia. Accuracy of the blood culture varies between8 and 73% in various studies .

Despite hundreds of published studies, there is still no consensus regarding the best screening test or panel of tests for rapid detection of neonatal sepsis. Recently, new acute phase proteins, cytokines, cell surface antigens, and bacterial genome are used to improve the neonatal sepsis diagnosis but data are still under evaluation and most of these tests are either not clinically available or they are expensive .

Accumulating evidence indicates that the CBC is an effective predictor of prognosis and mortality in many disease states, including hematological disease, neoplasms, and severe infections. Therefore, non- specific changes in the CBC in critically ill neonates could be considered a key prognostic factor in the evaluation of survival prediction in these patients .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates with suspected sepsis that show non-specific signs and symptoms or focal signs of infection, including temperature instability, hypotension, poor perfusion with pallor and mottled skin, metabolic acidosis, tachycardia or bradycardia, apnoea, respiratory distress, grunting, cyanosis, irritability, lethargy, seizures, feeding intolerance, abdominal distention, jaundice, petechiae, purpura, and bleeding. Later complications of sepsis might include respiratory failure, pulmonary hypertension, cardiac failure, shock, renal failure, liver dysfunction, cerebral edema or thrombosis, adrenal hemorrhage or insufficiency, bone marrow dysfunction (neutropenia, thrombocytopenia, anemia), and disseminated intravascular coagulation.
  • Cases with neonatal sepsis diagnosed by isolating the causative agent from a normally sterile body site (blood, CSF, urine, pleural, joint, and peritoneal fluids (Andi L Shaneetal, 2017).

排除标准

  • Obvious features of dehydration
  • Major congenital malformations.
  • GIT functional or organic obstruction, hematological disorders, hypersplenism, respiratory distress, malignancy and neurological emergency as intra cranial hemorrhage.
  • Hypoxic ischemic encephalopathy.
  • Post-surgical cases which need NICU observation.

结局指标

主要结局

white blood cells indices

时间窗: one year

total neutrophil count

Platelets indices

时间窗: one year

Mean platelet volume

white blood cells

时间窗: one year

total leucocytic count

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eslam Ahmad Roshdy

Principal investigator

Assiut University

研究点 (1)

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