Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of... | NCT03923543

Studies
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease

NCT03923543

Sponsor

Firat Ergin

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Sepsis Newborn

Interventions

Neutrophil to lymphosit ratio

Countries

Not provided

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 19, 2019

First Posted Date

Apr 22, 2019Actual

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

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery

Detailed Description

The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
Neutrophil to lymphosit ratio	Diagnostic Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neutrophil to Lymphocyte Ratio	We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes	1 day
Neutrophil to Lymphocyte Ratio	We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes	2 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborn to be operated with the diagnosis of congenital heart disease

Exclusion Criteria:

age older than 1 month not to be operated

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This study was conducted in the NICU of Tepecik Training and Research Hospital, İzmir,

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000071074	Neonatal Sepsis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided