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Early Diagnosis of Neonatal Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04105413
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
Fady Magdy Saber, Assiut University

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.

Condition or disease Intervention/treatment
Sepses, Neonatal Diagnostic Test: Blood culturs

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Diagnosis of Neonatal Sepsis Using Modified Hematological Scoring System
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Intervention Details:
  • Diagnostic Test: Blood culturs
    CBC, Blood culture and CRP

Primary Outcome Measures :
  1. Early detection of neonatal sepsia [ Time Frame: average 1 year ]
    To 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all neonates suspected neonatal sepsis

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

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Responsible Party: Fady Magdy Saber, principle investigator, Assiut University Identifier: NCT04105413    
Other Study ID Numbers: EDONS
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Sepsis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Infant, Newborn, Diseases