- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03354650
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
Studieoversikt
Detaljert beskrivelse
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 .
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
complete blood count
blood sample is collected from infant to detect presence of sepsis
|
blood culture to determine causative organisms of neonatal sepsis
Andre navn:
|
|
c reactive protein
measuring c reactive protein in blood sample to determine neonatal sepsis
|
blood culture to determine causative organisms of neonatal sepsis
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of neonatal sepsis
Tidsramme: up to 4 months
|
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
Tidsramme: up to 4 months
|
by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly
|
up to 4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
risk factors and causative organisms of neonatal sepsis
Tidsramme: up to 4 months
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Gehan Mo Kamal El_Din, Professor, Assiut University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EONI
Plan for individuelle deltakerdata (IPD)
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