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OpenTrials
Completed

NCT Number: NCT02010879

The Impact of Platelet Functions 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.

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Key information

Conditions

Patent Ductus Arterioses

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Children's Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. spontaneous ductal closure

    Time frame: 8 weeks

    ductal closure confirmed by echocardiography on postnatal 2-3 days

Secondary outcomes

  1. need for treatment

    Time frame: 8 weeks

    any need for medical treatment (ibuprofen or paracetamol) or surgical treatment

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study 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

Acronym: PFA100

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 13, 2013
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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