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

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04800445
• Other study ID #: MS-53-2020
• Status: Active, not recruiting
• Start date: April 4, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 10, 2022
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Salivary CRP
Salivary C reactive protein in neonatal sepsis

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo	Almanyal

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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