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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

196

Phase

  • 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

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
Intervention / Treatment
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

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

Seda Yilmaz Semerci

Investigators

  • 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)

July 4, 2017

Primary Completion (ACTUAL)

April 5, 2018

Study Completion (ACTUAL)

May 24, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 10, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 3, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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