The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants

NCT ID: NCT02010879

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Detailed Description

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Patent ductus arterioses is a common problem which involves both pulmonary and cardiac outcomes in preterm infants. Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure.

The investigators aim to investigate the relation between thrombocytopenia and platelet functions in pathogenesis of spontaneous ductal closure. The investigators hypothesize that Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Conditions

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Patent Ductus Arterioses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* gestational age lower than 30 weeks and birth weight lower than 1500 g
* obtained informed consent

Exclusion Criteria

* any received medical treatment in first 2 days of life
* death in first 2 days
* patients who received any thrombocyte or fresh frozen plasma suspensions
* any known genetic thrombocyte disorder in the family
Minimum Eligible Age

2 Days

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Omer Erdeve

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omer Erdeve, Professor

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara University Children's Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PDAPFA-100 TRIAL

Identifier Type: -

Identifier Source: org_study_id

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