Bronchopulmonary Displasia Clinical Trial
Official title:
Investigation of Polymorphisms Defined in Specific Genes Which Are Associated With Bronchopulmonary Dysplasia In Turkish Population
| NCT number | NCT03467828 |
| Other study ID # | 18 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 4, 2017 |
| Est. completion date | May 24, 2018 |
| Verified date | March 2019 |
| Source | Kanuni Sultan Suleyman Training and Research Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 196 |
| Est. completion date | May 24, 2018 |
| Est. primary completion date | April 5, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Kucukcekmece |
| Lead Sponsor | Collaborator |
|---|---|
| Seda Yilmaz Semerci |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DNA | Single nucleotide gene polymorphisms | 6 months |