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

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

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.

Study Overview

• Status: Unknown
• Conditions: Neonatal SEPSIS
• Intervention / Treatment: Diagnostic test: blood culture

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ghan M Kamal El_Din, Professor; Phone Number: Assiut 00201013706184; Email: Gehankamal1958@gmail.com
• Study Contact Backup: Name: Ismael L Mohammed, Assistant Pr; Phone Number: Assiut 00201063398967; Email: ismail231@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All admitted male and female infant from the birth to the day 30 after birth

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
complete blood count; blood sample is collected from infant to detect presence of sepsis	Diagnostic test: blood culture; blood culture to determine causative organisms of neonatal sepsis; Other Names: other cultures if needed
c reactive protein; measuring c reactive protein in blood sample to determine neonatal sepsis	Diagnostic test: blood culture; blood culture to determine causative organisms of neonatal sepsis; Other Names: other cultures if needed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Gehan Mo Kamal El_Din, Professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: October 28, 2017
• First Submitted That Met QC Criteria: November 26, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: EONI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No