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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03354650
Enrollment
100
Registered
2017-11-28
Start date
2018-01-01
Completion date
2019-07-01
Last updated
2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal SEPSIS

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 .

Interventions

DIAGNOSTIC_TESTblood culture

blood culture to determine causative organisms of neonatal sepsis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 4 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of neonatal sepsisup to 4 monthsby measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis
prevalence of neonatal sepsisup to 4 monthsby measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly

Secondary

MeasureTime frameDescription
risk factors and causative organisms of neonatal sepsisup to 4 monthsby 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

Contacts

Primary ContactGhan M Kamal El_Din, Professor
Gehankamal1958@gmail.com00201013706184
Backup ContactIsmael L Mohammed, Assistant Pr
ismail231@aun.edu.eg00201063398967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026