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White Blood Cells and Platelets Indices as a Prognostic Factor in Neonatal Sepsis

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ClinicalTrials.gov Identifier: NCT03880305
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eslam Ahmad Roshdy, Assiut University

Brief Summary:
Sepsis is a complex condition initiated by a pathogen and mediated by cytokines followed by immune, inflammatory, and coagulation homeostasis disturbances, its evolution being dictated by a complicated balance between pro inflammatory and anti- inflammatory factors. Most of the short and long-term complications of the neonatal sepsis are strictly related to inflammatory mediators. Neonatal sepsis is associated with a mortality rate that ranges from 13 to 60% inspite of improved antibiotic therapy and an increased morbidity in survivors .

Condition or disease Intervention/treatment
Neonatal Sepsis Diagnostic Test: complete blood count

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Days
Official Title: White Blood Cells and Platelets Indices as a Prognostic Factor in Neonatal Sepsis
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: complete blood count
    complete blood count
    Other Name: blood culture


Primary Outcome Measures :
  1. white blood cells [ Time Frame: one year ]
    total leucocytic count

  2. white blood cells indices [ Time Frame: one year ]
    total neutrophil count

  3. Platelets indices [ Time Frame: one year ]
    Platelet count

  4. Platelets indices [ Time Frame: one year ]
    Platelet distribution width(PDW)

  5. Platelets indices [ Time Frame: one year ]
    Mean platelet volume



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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
newborns with neonatal sepsis
Criteria

Inclusion Criteria:

  1. Neonates with suspected sepsis that show non-specific signs and symptoms or focal signs of infection, including temperature instability, hypotension, poor perfusion with pallor and mottled skin, metabolic acidosis, tachycardia or bradycardia, apnoea, respiratory distress, grunting, cyanosis, irritability, lethargy, seizures, feeding intolerance, abdominal distention, jaundice, petechiae, purpura, and bleeding. Later complications of sepsis might include respiratory failure, pulmonary hypertension, cardiac failure, shock, renal failure, liver dysfunction, cerebral edema or thrombosis, adrenal hemorrhage or insufficiency, bone marrow dysfunction (neutropenia, thrombocytopenia, anemia), and disseminated intravascular coagulation.
  2. Cases with neonatal sepsis diagnosed by isolating the causative agent from a normally sterile body site (blood, CSF, urine, pleural, joint, and peritoneal fluids (Andi L Shaneetal, 2017).

Exclusion Criteria:

  1. Obvious features of dehydration
  2. Major congenital malformations.
  3. GIT functional or organic obstruction, hematological disorders, hypersplenism, respiratory distress, malignancy and neurological emergency as intra cranial hemorrhage.
  4. Hypoxic ischemic encephalopathy.
  5. Post-surgical cases which need NICU observation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880305


Contacts
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Contact: Eslam A Roshdy 00201066962696 iroshdy92@gmail.com

Locations
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Egypt
Eslam Ahmad Roshdy Recruiting
Assiut, Egypt
Contact: Eslam A Roshdy, Physician    00201066962696    iroshdy2@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Eslam A Roshdy Assiut University Faculty of Medicine

Additional Information:

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Responsible Party: Eslam Ahmad Roshdy, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03880305     History of Changes
Other Study ID Numbers: WBCPLATNS
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: all collected IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eslam Ahmad Roshdy, Assiut University:
neonatal sepsis
white blood cells
platelets

Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases