Neural Tube DefectsNCT04135274

Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?

An observational study of Neural Tube Defects and Newborn Sepsis, run by Tepecik Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages Up to 28 days
Conditions the study is for: Neural Tube Defects, Newborn Sepsis
What is being tested?: Neutrophil to lymphocyte ratio
How many people: 57 participants
Where: No sites listed yet
Study dates: 1 Jan 2015to 30 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 Up to 28 days
All sexes
Child

Study population: < 28 days infants

Who may be able to join

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

Who cannot join

>28 days

About this study

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

Conditions: Neural Tube Defects, Newborn Sepsis
Being tested: Neutrophil to lymphocyte ratio
Medical subject headings: Neural Tube Defects, Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neutrophil to lymphocyte ratioDiagnostic test
Neutrophil to lymphocyte ratio

Study groups in NCT04135274
Study group	Role	What they receive
Sepsis group		Not described Receives: Diagnostic Test: Neutrophil to lymphocyte ratio
Non Sepsis group		Not described Receives: Diagnostic Test: Neutrophil to lymphocyte ratio

What is being measured

The primary outcome is the main question the study is designed to answer.

Neutrophil to lymphocyte ratio is prognostic faktör for Sepsis
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201530 Dec 2018

First posted22 Oct 2019
Study start1 Jan 2015
Primary completion30 Dec 2018
Study completion30 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neural Tube DefectsStudies 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: 57 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT04135274
Sponsor's protocol ID: 2018/12- 7
Status last verified: Oct 2019
First submitted: 19 Oct 2019
Last updated: 22 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Neural Tube Defects (NTDs)

All Neural Tube Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 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 Neural Tube Defects?
ClinicalTrials.gov ID: NCT04135274
Acronym / sponsor ID: 2018/12- 7
Conditions: Neural Tube Defects, Newborn Sepsis
Study type: Observational
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Tepecik Training and Research HospitalUniversity, hospital or other
Study start: 1 Jan 2015 (actual)
Primary completion: 30 Dec 2018 (actual)
Study completion: 30 Dec 2018 (actual)
First posted: 22 Oct 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.

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

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 2

Arm	Type	Receives
Sepsis group	–	Diagnostic Test: Neutrophil to lymphocyte ratio
Non Sepsis group	–	Diagnostic Test: Neutrophil to lymphocyte ratio

Who may qualify

Ages: Up to 28 days
Sex: All
Age groups: Child
Study population: < 28 days infants

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

>28 days

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 lymphocyte ratioNeutrophil to lymphocyte ratio	Diagnostic test	Non Sepsis group, Sepsis group

Primary outcome

Neutrophil to lymphocyte ratio is prognostic faktör for Sepsis
Time frame: 3 years

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 Oct 2019.
Individual participant dataSharing planned: Undecided

Related trials for Neural Tube Defects

Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
Neural Tube Defects (NTDs)

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 Neural Tube Defects and Newborn Sepsis, run by Tepecik Training and Research Hospital.

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 Oct 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 is prognostic faktör for Sepsis (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04135274.

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 Oct 2019.