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CompletedNCT03467828Updated Mar 5, 2019

Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population

An interventional study of polymorphism analyzing in Bronchopulmonary Displasia, sponsored by Seda Yilmaz Semerci. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Seda Yilmaz Semerci · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Bronchopulmonary Displasia
03

In context

Lead sponsor

This is the only study on the registry with Seda Yilmaz Semerci as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • major congenital abnormalities
  • lack of data
  • parents don't agree with informed consent
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (actual)

Study arms

  • Experimental
    Study Group

    Infants diagnosed with BPD.

    Genetic: polymorphism analyzing

  • No intervention
    Control Group

    Infants born in similar gestational week and birth weight but not diagnosed with BPD.

Interventions

  • Geneticpolymorphism analyzing

    Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.

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What researchers measure

Primary outcomes

  1. DNA

    Single nucleotide gene polymorphisms

    Time frame: 6 months

07

Study locations

1 site
  • Kanuni Sultan Suleyman Training and Research Hospital
    Istanbul, Kucukcekmece 34303, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 34853430 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Apr 2018, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 16, 2018
StartActual
Jul 4, 2017
Primary completionActual
Apr 5, 2018
CompletionActual
May 24, 2018
Last update
Mar 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03467828
Lead sponsor
Seda Yilmaz Semerci
Responsible party
Seda Yilmaz Semerci (Neonatologist, MD, Kanuni Sultan Suleyman Training and Research Hospital) — Sponsor-investigator
First posted
Mar 16, 2018
Start date
Jul 4, 2017
Primary completion
Apr 5, 2018
Completion
May 24, 2018
Last update
Mar 5, 2019

Study contacts

Seda Yilmaz Semerci
study chair · Kanuni Sultan Suleyman Training and Research Hospital
Ayberk Akat
principal investigator · Istanbul Demiroglu Bilim University
Osman Mutluhan Ugurel
study chair · Yildiz Technical University
Merih Cetinkaya
study director · Kanuni Sultan Suleyman Training and Research Hospital
Dilek Turgut Balık
study director · Yildiz Technical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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