Sepsis NewbornNCT03923543
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease
An observational study of Sepsis Newborn, run by Firat Ergin.
Trial summary
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis Newborn
- What is being tested?
- Neutrophil to lymphosit ratio
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: This study was conducted in the NICU of Tepecik Training and Research Hospital, İzmir,
Who may be able to join
- newborn to be operated with the diagnosis of congenital heart disease
Who cannot join
- age older than 1 month not to be operated
About this study
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery
Read the 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
- Conditions
- Sepsis Newborn
- Being tested
- Neutrophil to lymphosit ratio
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil to lymphosit ratioDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to Lymphocyte Ratio
We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes
Measured: 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
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Firat Ergin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Firat Ergin, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923543
- Sponsor's protocol ID
- (2018/12- 7
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03923543
- Acronym / sponsor ID
- (2018/12- 7
- Conditions
- Sepsis Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat ErginUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study was conducted in the NICU of Tepecik Training and Research Hospital, İzmir,
Key inclusion criteria (1 listed)
- newborn to be operated with the diagnosis of congenital heart disease
Key exclusion criteria (1 listed)
- age older than 1 month not to be operated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutrophil to lymphosit ratio | Diagnostic test | – |
Primary outcome
Neutrophil to Lymphocyte Ratio
Time frame: 1 day
We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes
Neutrophil to Lymphocyte Ratio
Time frame: 2 week
We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
Related trials for Sepsis Newborn
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Chronic Granulomatous Disease, Infection
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
G-CSF In Neonatal Sepsis With Neutropenia
Neonatal Sepsis, Neutropenia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Newborn, run by Firat Ergin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil to Lymphocyte Ratio (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.