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

• Conditions: Neonatal SEPSIS
• Interventions: Diagnostic Test: blood culture

• Registration Number: NCT03354650
• Lead Sponsor: Assiut University

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2017-10-28
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-26
• Study First Posted: 2017-11-28
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-05
• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All admitted inborn and out born neonates during this study period will be screened for sepsis

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complete blood count	blood culture	blood sample is collected from infant to detect presence of sepsis
c reactive protein	blood culture	measuring c reactive protein in blood sample to determine neonatal sepsis

Primary Outcome Measures

Name	Time	Method
Incidence of neonatal sepsis	up to 4 months	by measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis
prevalence of neonatal sepsis	up to 4 months	by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly

Secondary Outcome Measures

Name	Time	Method
risk factors and causative organisms of neonatal sepsis	up to 4 months	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