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

NCT03880305 | Unknown

• 1 other identifier: WBCPLATNS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Neonatal Sepsis

Keywords

neonatal sepsis; white blood cells; platelets

Outcome Measures

Primary Outcomes (5)

• white blood cells

  total leucocytic count

  one year

• white blood cells indices

  total neutrophil count

  one year

• Platelets indices

  Platelet count

  one year

• Platelets indices

  Platelet distribution width(PDW)

  one year

• Platelets indices

  Mean platelet volume

  one year

Interventions

complete blood count DIAGNOSTIC_TEST

complete blood count

Also known as: blood culture

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

newborns with neonatal sepsis

You may qualify if:

• 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.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Eslam Ahmad Roshdy

Asyut, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Blood Cell Count; Blood Culture

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Microbiological Techniques

Study Officials

• Eslam A Roshdy

  Assiut University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eslam A Roshdy

CONTACT

00201066962696; iroshdy92@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: March 31, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

EG (1)