Salivary C- Reactive Protein, Mean Platelet Volume and Ne... | NCT04800445

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

NCT04800445

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 9, 2021Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Neonatal Sepsis

Interventions

Salivary CRP

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2020Actual

Primary Completion Date

Dec 4, 2020Actual

Completion Date

Jan 10, 2022Estimated

First Submitted Date

Feb 26, 2021

First Submission Date that Met QC Criteria

Mar 14, 2021

First Posted Date

Mar 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2021

Last Update Posted Date

Aug 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case group of fullterm neonates with neonatal sepsis			Diagnostic Test: Salivary CRP
Healthy fullterm neonates			Diagnostic Test: Salivary CRP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salivary CRP	Diagnostic Test	Salivary C reactive protein in neonatal sepsis	Case group of fullterm neonates with neonatal sepsis Healthy fullterm neonates

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

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.

Sampling Method

Probability Sample

ID	Term
D018805	Sepsis
D007239	Infections
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities