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

NCT03354650 | Unknown

• 1 other identifier: EONI
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal SEPSIS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• risk factors and causative organisms of neonatal sepsis

  up to 4 months

Study Arms (2)

complete blood count

blood sample is collected from infant to detect presence of sepsis

Diagnostic Test: blood culture

c reactive protein

measuring c reactive protein in blood sample to determine neonatal sepsis

Diagnostic Test: blood culture

Interventions

blood culture DIAGNOSTIC_TEST

blood culture to determine causative organisms of neonatal sepsis

Also known as: other cultures if needed

c reactive protein; complete blood count

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Blood Culture

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Gehan Mo Kamal El_Din, Professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Ghan M Kamal El_Din, Professor

CONTACT

00201013706184; Gehankamal1958@gmail.com

Ismael L Mohammed, Assistant Pr

CONTACT

00201063398967; ismail231@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 5, 2017

Record last verified: 2017-11