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Early Diagnosis of Neonatal Sepsis

Early Diagnosis of Neonatal Sepsis Using Modified Hematological Scoring System

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04105413
Enrollment
100
Registered
2019-09-26
Start date
2019-09-30
Completion date
2021-04-30
Last updated
2019-09-26

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

Conditions

Sepses, Neonatal

Brief summary

Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection.

Detailed description

Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection..Worldwide, neonatal sepsis is responsible for 4 million deaths annually and 99% of them occur in developing countries.. . morbidity associated with sepsis includes sensorineural hearing loss, visual disturbances, seizures, and neurodevelopmental issues.. Blood culture is considered as gold standard for diagnosis of sepsis. The ideal diagnostic test should be inexpensive, have quick results Hematologic scoring system(HSS) of Rodwell et al. includes the following: a) White blood cell and platelet count b) White blood differential count c) Nucleated red blood cell count (to correct WBC count) d) Assessment of neutrophil morphology for degenerative changes. A modified HSS(modified hematological scoring system) was developed by removing the repetitive parameters, adding a new parameter - nucleated RBC.

Interventions

DIAGNOSTIC_TESTBlood culturs

CBC, Blood culture and CRP

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days

Inclusion criteria

* Newborns with history of prolonged rupture of membranes, maternal intrapartum fever or non specific signs of sepsis namely; neonatal fever or hypothermia , poor feeding ,lethargy, irritability, depressed neonatal reflexes ,respiratory distress including apnea or cyanosis,hypoxia,poor capillary perfusion,bradycardia,hypotension,pallor,edema,vomiting,diarrhea,abdominal distention, bulging anterior fontanelle,coma,seizures,unexplained jaundice, reduced suckling, bleeding problems,hypoglycemia,hyperglycemia or metabolic acidosis were included in the study

Exclusion criteria

* All the newborn babies with history of delayed cry, meconium aspiration, congenital anomaly, history of antibiotics administration prior to admission to the baby or mother, intrapartum and neonatal death in sibling with similar presentation will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Early detection of neonatal sepsiaaverage 1 yearTo determine the accuracy of a simple and cost effective Modified hematological scoring system in the early diagnosis of neonatal sepsis using blood culture as a gold standard in neonates attending Neonatology Unit of Assiut University Children Hospital

Outcome results

None listed

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