Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital

Study Overview
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Brief Summary
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Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.

Detailed Description
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More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year. The majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity . Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis. Diagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis . Neonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .

Official Title
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Epidemiology of Neonatal Sepsis in Infants Admitted to Neonatal Intensive Care Unit in Assiut University Children Hospital

Conditions
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Neonatal SEPSIS

Intervention / Treatment
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* Diagnostic Test: blood culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All admitted inborn and out born neonates during this study period will be screened for sepsis Exclusion Criteria: • All cases that mimic neonatal sepsis such as; Inborn errors of metabolism Congestive heart failure Hemolytic Disease of Newborn Hypoxic ischemic encephalopathy Congenital Diaphragmatic Hernia Intra cranial hemorrhage Respiratory Distress Syndrome

Ages Eligible for Study
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Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| complete blood count<br>blood sample is collected from infant to detect presence of sepsis | Diagnostic Test: blood culture<br>* blood culture to determine causative organisms of neonatal sepsis<br>* Other names: other cultures if needed;|
| c reactive protein<br>measuring c reactive protein in blood sample to determine neonatal sepsis | Diagnostic Test: blood culture<br>* blood culture to determine causative organisms of neonatal sepsis<br>* Other names: other cultures if needed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neonatal sepsis | by measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis | up to 4 months | 
| prevalence of neonatal sepsis | by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors and causative organisms of neonatal sepsis | by determining the relation between risk factors and incidence of neonatal sepsis and by determining the causative organisms this help in prevention and management of neonatal sepsis | up to 4 months |