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

NCT04800445 | Unknown

• 1 other identifier: MS-53-2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean platelet volume

  28 days

Study Arms (2)

Case group of fullterm neonates with neonatal sepsis

Diagnostic Test: Salivary CRP

Healthy fullterm neonates

Diagnostic Test: Salivary CRP

Interventions

Salivary CRP DIAGNOSTIC_TEST

Salivary C reactive protein in neonatal sepsis

Case group of fullterm neonates with neonatal sepsis; Healthy fullterm neonates

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine

Cairo, Almanyal, 11562, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency medicine and traumatology resident in sharq el madina hospital

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 16, 2021
• Study Start: April 4, 2020
• Primary Completion: December 4, 2020
• Study Completion: January 10, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

EG (1)