The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants (PFA100)

April 23, 2016 updated by: Omer Erdeve, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

preterm infants with gestational age below 30 weeks and birth weght lower than 1500 g

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spontaneous ductal closure
Time Frame: 8 weeks
ductal closure confirmed by echocardiography on postnatal 2-3 days
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for treatment
Time Frame: 8 weeks
any need for medical treatment (ibuprofen or paracetamol) or surgical treatment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Ömer Erdeve, Professor, Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 23, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDAPFA-100 TRIAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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