Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population
Primary Purpose
Bronchopulmonary Displasia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
polymorphism analyzing
Sponsored by
About this trial
This is an interventional screening trial for Bronchopulmonary Displasia
Eligibility Criteria
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
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study Group
Control Group
Arm Description
Infants diagnosed with BPD.
Infants born in similar gestational week and birth weight but not diagnosed with BPD.
Outcomes
Primary Outcome Measures
DNA
Single nucleotide gene polymorphisms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03467828
Brief Title
Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population
Official Title
Investigation of Polymorphisms Defined in Specific Genes Which Are Associated With Bronchopulmonary Dysplasia In Turkish Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seda Yilmaz Semerci
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Displasia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Infants diagnosed with BPD.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Infants born in similar gestational week and birth weight but not diagnosed with BPD.
Intervention Type
Genetic
Intervention Name(s)
polymorphism analyzing
Intervention Description
Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.
Primary Outcome Measure Information:
Title
DNA
Description
Single nucleotide gene polymorphisms
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda Yilmaz Semerci
Organizational Affiliation
Kanuni Sultan Suleyman Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayberk Akat
Organizational Affiliation
Istanbul Demiroglu Bilim University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osman Mutluhan Ugurel
Organizational Affiliation
Yildiz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Merih Cetinkaya
Organizational Affiliation
Kanuni Sultan Suleyman Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dilek Turgut Balık
Organizational Affiliation
Yildiz Technical University
Official's Role
Study Director
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34303
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
34853430
Citation
Akat A, Yilmaz Semerci S, Ugurel OM, Erdemir A, Danhaive O, Cetinkaya M, Turgut-Balik D. Bronchopulmonary dysplasia and wnt pathway-associated single nucleotide polymorphisms. Pediatr Res. 2022 Sep;92(3):888-898. doi: 10.1038/s41390-021-01851-6. Epub 2021 Dec 1.
Results Reference
derived
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Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population
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