NCT04135274

Brief Summary

We aimed to investigate whether Neutrophil Lymphocyte Ratio is a Prognostic Factor of Sepsis in Newborns with operated Neural Tube Defects?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
57

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 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

October 19, 2019

Last Update Submit

October 19, 2019

Conditions

Neural Tube DefectsNewborn Sepsis

Outcome Measures

Primary Outcomes (1)

  • Neutrophil to lymphocyte ratio is prognostic faktör for Sepsis

    3 years

Study Arms (2)

Sepsis group

Diagnostic Test: Neutrophil to lymphocyte ratio

Non Sepsis group

Diagnostic Test: Neutrophil to lymphocyte ratio

Interventions

Neutrophil to lymphocyte ratioDIAGNOSTIC_TEST

Neutrophil to lymphocyte ratio

Non Sepsis groupSepsis group

Eligibility Criteria

AgeUp to 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

\< 28 days infants

You may qualify if:

  • \<28 days diagnosed with with neural Tüpe Defects To be operated

You may not qualify if:

  • \>28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neural Tube DefectsNeonatal Sepsis

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSepsisInfectionsInfant, Newborn, DiseasesSystemic 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
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 22, 2019

Study Start

January 1, 2015

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10