Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels

NCT04508036 | Unknown

• 1 other identifier: KA-19033
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether there is a relationship between echocardiographic measurements regarding closure of PDA and serum D-Dimer and Fibrinogen levels in premature infants born before 32nd gestational week and weighing less than 1500 grams.

Conditions

Ductus Arteriosus, Patent

Keywords

Premature Newborn; Ductus Arteriosus; D-Dimer; Fibrinogen

Outcome Measures

Primary Outcomes (2)

• Rise in D-dimer blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days

  It is postulated that circulating D-dimer levels will increase gradually as a by-product due to thrombosis in the lumen during DA closure from postnatal day 0 to postnatal 3rd and 7th days. It is predicted that D-dimer levels will be lower in infants in whom DA does not close than in infants whom DA is closed. Blood samples are withdrawn accordingly at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for D-dimer levels.

  postnatal 0 - 14 days

• Fall in Fibrinogen blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days

  It is postulated that circulating fibrinogen levels will fall gradually due to thrombosis in the lumen during DA closure from postnatal day 0 to postnatal 3rd and 7th days. It is predicted that fibrinogen levels will be higher in infants in whom DA does not close than in infants whom DA is closed. Blood samples are withdrawn accordingly at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for fibrinogen levels.

  postnatal 0 - 14 days

Study Arms (1)

Study Group

Premature newborns born before 32nd gestational week and weighing less than 1500 grams.

Diagnostic Test: Withdrawal of blood samples for D-Dimer; Diagnostic Test: Withdrawal of blood samples for Fibrinogen; Diagnostic Test: Echocardiographic Examination

Interventions

Withdrawal of blood samples for D-Dimer DIAGNOSTIC_TEST

Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for D-dimer levels.

Study Group

Withdrawal of blood samples for Fibrinogen DIAGNOSTIC_TEST

Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for Fibrinogen levels.

Study Group

Echocardiographic Examination DIAGNOSTIC_TEST

At postnatal 3rd, 7th and 14th days, Ductus Arteriosus will be echocardiographically examined to obtain calculations and confirm status of ductal patency or closure.

Study Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

otherwise healthy premature newborns born before 32nd gestational week and weighing less than 1500 grams.

You may qualify if:

• premature newborns born before 32nd gestational week and weighing less than 1500 grams.

You may not qualify if:

• Babies with:
• Major congenital anomalies
• Chromosomal anomalies
• Inborn errors of metabolism
• Hypoxic ischemic encephalopathy
• Disseminated intravascular coagulation
• Unstable hemodynamic status
• Severe neonatal sepsis
• Who died in time frame of postnatal 14 days
• Patients who are not volunteered to participate

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Tay SP, Cheong SK, Boo NY. Circulating tissue factor, tissue factor pathway inhibitor and D-dimer in umbilical cord blood of normal term neonates and adult plasma. Blood Coagul Fibrinolysis. 2003 Feb;14(2):125-9. doi: 10.1097/00001721-200302000-00002.

  PMID: 12632021 BACKGROUND

• Sehgal A, Paul E, Menahem S. Functional echocardiography in staging for ductal disease severity : role in predicting outcomes. Eur J Pediatr. 2013 Feb;172(2):179-84. doi: 10.1007/s00431-012-1851-0. Epub 2012 Oct 11.

  PMID: 23052621 BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hasan Tolga Çelik

  Hacettepe University

  STUDY CHAIR

• Alper Aykanat

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• İlker Ertuğrul

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Tolga Çelik

CONTACT

+90 530 592 55 84; htcelik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neonatology

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 11, 2020
• Study Start: March 14, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

TU (1)