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

• Conditions: Neonatal Sepsis
• Interventions: Diagnostic Test: Salivary CRP

• Registration Number: NCT04800445
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-04
• Primary Completion: 2020-12-04
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09
• Study Completion: 2022-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy fullterm neonates	Salivary CRP	-
Case group of fullterm neonates with neonatal sepsis	Salivary CRP	-

Primary Outcome Measures

Name	Time	Method
Salivary c reactive protein in neonatal sepsis	28 days	Salivary C reactive protein of value as non invasive procedure in diagnosis of neonatal sepsis

Secondary Outcome Measures

Name	Time	Method
Mean platelet volume	28 days	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

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Cairo, Almanyal, Egypt