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

NCT ID: NCT04800445

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-04

Study Completion Date

2022-01-10

Brief Summary

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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

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Conditions

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Neonatal Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group of fullterm neonates with neonatal sepsis

Salivary CRP

Intervention Type DIAGNOSTIC_TEST

Salivary C reactive protein in neonatal sepsis

Healthy fullterm neonates

Salivary CRP

Intervention Type DIAGNOSTIC_TEST

Salivary C reactive protein in neonatal sepsis

Interventions

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Salivary CRP

Salivary C reactive protein in neonatal sepsis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eslam Mohamed Naeim

Emergency medicine and traumatology resident in sharq el madina hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Cairo, Almanyal, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-53-2020

Identifier Type: -

Identifier Source: org_study_id

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