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

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Patent ductus arteriosus
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Brief Title

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

Official Title

The Impact of Platelet Count, Platelet Mass Index and Platelet Function Evaluated by Platelet Function Analyzer (PFA-100) on Spontaneous Ductal Closure in Preterm Infants

Brief Summary

      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

      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.

Study Type

Observational

Primary Outcome

spontaneous ductal closure

Secondary Outcome

 need for treatment

Condition

Patent Ductus Arterioses

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

80

Start Date

December 2013

Completion Date

January 2015

Primary Completion Date

December 2014

Eligibility Criteria

        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

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Omer Erdeve, Professor, ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT02010879

Organization ID

PDAPFA-100 TRIAL

Responsible Party

Principal Investigator

Study Sponsor

Ankara University

Study Sponsor

Omer Erdeve, Professor, Principal Investigator, Ankara University

Verification Date

April 2016