Salivary C- Reactive Protein, Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis

Salivary C-reactive Protein,Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis

To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis

Study Overview

• Status: Active, not recruiting
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Diagnostic test: Salivary CRP

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Almanyal
    • Cairo, Almanyal, Egypt, 11562
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Full term neonates of both genders from birth to the 28th day of life who were admitted to Cairo University NICU with clinical features of either early- or late-onset neonatal sepsis diagnosed by culture, CRP more than 10 ,and has three or more the clinical findings of sepsis were enrolled in this study.

Neonates with no symptoms or signs suggestive 0f sepsis who had been hospitalized In Cairo University Nicu . Serum CRP level for neonates in this group was negative (CRP < 10 mg/L) as control group.

Description

Inclusion Criteria:

• - Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following:
• (1) temperature instability (hypothermia, hyperthermia) .
• (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) .
• (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) .
• (4) neurologic alterations (hypotonia, lethargy, seizures)
• (5) gastrointestinal alterations (feeding intolerance, abdominal distension). CRP values >10 mg/L were considered to be positive.

Exclusion Criteria:

• - Preterm neonates .
• Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group of fullterm neonates with neonatal sepsis	Diagnostic test: Salivary CRP; Salivary C reactive protein in neonatal sepsis
Healthy fullterm neonates	Diagnostic test: Salivary CRP; Salivary C reactive protein in neonatal sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary c reactive protein in neonatal sepsis	Salivary C reactive protein of value as non invasive procedure in diagnosis of neonatal sepsis	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean platelet volume	Asses the validity of Mean Platlet Volume as marker of neonatal sepsis which is equal about ( 9 - 11.4 ) in septic group and about ( 7.5 - 8.5 ) in control group	28 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2020
• Primary Completion (Actual): December 4, 2020
• Study Completion (Anticipated): January 10, 2022

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: MS-53-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No