Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population

NCT03467828 | Completed

• 1 other identifier: 18
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Displasia

Outcome Measures

Primary Outcomes (1)

• DNA

  Single nucleotide gene polymorphisms

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

Infants diagnosed with BPD.

Genetic: polymorphism analyzing

Control Group

NO INTERVENTION

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

Interventions

polymorphism analyzing GENETIC

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

Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seda Yilmaz Semerci: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34853430 DERIVED

Study Officials

• Seda Yilmaz Semerci

  Kanuni Sultan Suleyman Training and Research Hospital

  STUDY CHAIR

• Ayberk Akat

  Istanbul Demiroglu Bilim University

  PRINCIPAL INVESTIGATOR

• Osman Mutluhan Ugurel

  Yildiz Technical University

  STUDY CHAIR

• Merih Cetinkaya

  Kanuni Sultan Suleyman Training and Research Hospital

  STUDY DIRECTOR

• Dilek Turgut Balık

  Yildiz Technical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist, MD

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 16, 2018
• Study Start: July 4, 2017
• Primary Completion: April 5, 2018
• Study Completion: May 24, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

TU (1)