Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population

March 3, 2019 updated by: Seda Yilmaz Semerci

Investigation of Polymorphisms Defined in Specific Genes Which Are Associated With Bronchopulmonary Dysplasia In Turkish Population

Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bronchopulmonary dysplasia is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants born under 30 gestational week
  • infants with bronchopulmonary displasia

Exclusion Criteria:

  • major congenital abnormalities
  • lack of data
  • parents don't agree with informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Study Group
Infants diagnosed with BPD.
Genetic: polymorphism analyzing
Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.
NO_INTERVENTION: Control Group
Infants born in similar gestational week and birth weight but not diagnosed with BPD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DNA
Time Frame: 6 months
Single nucleotide gene polymorphisms
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seda Yilmaz Semerci

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
  • Principal Investigator: Ayberk Akat, Istanbul Demiroglu Bilim University
  • Study Chair: Osman Mutluhan Ugurel, Yildiz Technical University
  • Study Director: Dilek Turgut Balık, Yildiz Technical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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