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

Neonatal SEPSIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03354650
• Other study ID #: EONI
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2017
• Last updated: December 3, 2017
• Start date: January 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: Ghan M Kamal El_Din, Professor
• Phone: 00201013706184
• Email: Gehankamal1958[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal SEPSIS
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• blood culture
blood culture to determine causative organisms of neonatal sepsis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	prevalence of neonatal sepsis	by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly	up to 4 months
Secondary	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