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

NCT ID: NCT03354650

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-07-01

Brief Summary

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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

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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 .

Conditions

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Neonatal SEPSIS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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complete blood count

blood sample is collected from infant to detect presence of sepsis

blood culture

Intervention Type DIAGNOSTIC_TEST

blood culture to determine causative organisms of neonatal sepsis

c reactive protein

measuring c reactive protein in blood sample to determine neonatal sepsis

blood culture

Intervention Type DIAGNOSTIC_TEST

blood culture to determine causative organisms of neonatal sepsis

Interventions

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blood culture

blood culture to determine causative organisms of neonatal sepsis

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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other cultures if needed

Eligibility Criteria

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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
Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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MSHAhmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gehan Mo Kamal El_Din, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Ghan M Kamal El_Din, Professor

Role: CONTACT

Phone: 00201013706184

Email: [email protected]

Ismael L Mohammed, Assistant Pr

Role: CONTACT

Phone: 00201063398967

Email: [email protected]

Other Identifiers

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EONI

Identifier Type: -

Identifier Source: org_study_id