ClinicalTrials.Veeva

Menu

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

A

Assiut University

Status

Unknown

Conditions

Neonatal SEPSIS

Treatments

Diagnostic Test: blood culture

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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 .

Enrollment

100 estimated patients

Sex

All

Ages

Under 4 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

complete blood count
Description:
blood sample is collected from infant to detect presence of sepsis
Treatment:
Diagnostic Test: blood culture
c reactive protein
Description:
measuring c reactive protein in blood sample to determine neonatal sepsis
Treatment:
Diagnostic Test: blood culture

Trial contacts and locations

0

Loading...

Central trial contact

Ghan M Kamal El_Din, Professor; Ismael L Mohammed, Assistant Pr

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems