NCT03923543

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

April 17, 2019

Last Update Submit

April 19, 2019

Conditions

Sepsis Newborn

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Neutrophil to lymphosit ratioDIAGNOSTIC_TEST

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • newborn to be operated with the diagnosis of congenital heart disease

You may not qualify if:

  • age older than 1 month not to be operated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Fırat ERGİN

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 22, 2019

Record last verified: 2019-04