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

Patent Ductus Arterioses Clinical Trial

— PFA100  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010879
• Other study ID #: PDAPFA-100 TRIAL
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: April 23, 2016
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arterioses

Locations

Country	Name	City	State
Turkey	Ankara University Children's Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spontaneous ductal closure	ductal closure confirmed by echocardiography on postnatal 2-3 days	8 weeks	No
Secondary	need for treatment	any need for medical treatment (ibuprofen or paracetamol) or surgical treatment	8 weeks	No