Ductus Arteriosus, PatentNCT04508036
Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels
An observational study of Ductus Arteriosus, Patent, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Withdrawal of blood samples for D-Dimer, Withdrawal of blood samples for Fibrinogen and Echocardiographic Examination
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: otherwise healthy premature newborns born before 32nd gestational week and weighing less than 1500 grams.
Who may be able to join
- premature newborns born before 32nd gestational week and weighing less than 1500 grams.
Who cannot join
- Babies with:
- Major congenital anomalies
- Chromosomal anomalies
- Inborn errors of metabolism
- Hypoxic ischemic encephalopathy
- Disseminated intravascular coagulation
Show all 10Show fewer
- Unstable hemodynamic status
- Severe neonatal sepsis
- Who died in time frame of postnatal 14 days
- Patients who are not volunteered to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Hasan Tolga Çelik, +90 530 592 55 84, htcelik@gmail.com
Alper Aykanat
About this study
Official title: The Relationship of Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels in Premature Babies
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.
Read the detailed description
Ductus arteriosus (DA) is located between the main pulmonary artery and descending aorta in embryonal life, with dense spiral-located smooth muscle cells in the media layer, and the intima layer is thicker than the aorta. It must be open in fetal life; in this way, the blood flowing from the right ventricle to the collapsed lungs is directed to the descending aorta. DA usually closes "functionally" by constriction of the media during the first three days after labor. In the second week after birth; endothelial folding, subendothelial proliferation and coagulation processes results in "anatomical" permanent closure.
When not closed, patent ductus arteriosus (PDA) is formed resulting in shunting from aorta to pulmonary artery. Probability of patency is inversely related with birth weight. Risk of pulmonary edema, pulmonary hemorrhage, bronchopulmonary dysplasia and loss of pulmonary function increases due to increased pulmonary flow from left to right shunt. Renal, mesenteric and cranial blood supply are impaired due to reduced peripheral circulation. As a result, impaired renal function and necrotizing enterocolitis may develop. Risk of intracranial hemorrhage, cerebral hypoxia and premature retinopathy due to variable blood supply. It has been associated with increased mortality in newborns due to increased morbidity. On physical examination, hyperdynamic precordium, viable pulses and left ventricular hypertrophy are observed. Large PDAs are characterized by prominent pulmonary conus, increased pulmonary vascularization and cardiomegaly on telecardiography.
Diagnosis of PDA is confirmed by echocardiography. Symptomatic PDA treatment and follow-up is mostly followed by echocardiography. Detailed echocardiographic examination can only be performed by a Pediatric Cardiologist, but it is not possible to evaluate DA at any time. It is necessary to benefit from significant changes in specific hematological parameters that may accompany DA closure in order to detect and predict these conditions.
One of the main mechanisms involved in anatomic permanent closure in DA is platelet aggregation and coagulation. To the best of our knowledge, there is no study in the literature investigating whether there is a relationship between Fibrinogen and D-dimer levels and anatomical closure of DA. It is postulated that circulating fibrinogen levels will decrease and D-dimer levels increase as a by-product due to thrombosis in the lumen during DA closure. It is predicted that in infants in whom DA does not close and remain open, fibrinogen levels will be higher and D-dimer levels will be lower than infants in whom DA is closed. It is also suggested that echocardiographic DA measurements will correlate with serum Fibrinogen and D-Dimer levels.
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
- Being tested
- Withdrawal of blood samples for D-Dimer, Withdrawal of blood samples for Fibrinogen, Echocardiographic Examination
- Keywords
- Premature Newborn, Ductus Arteriosus, D-Dimer, Fibrinogen
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of blood samples for D-DimerDiagnostic 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.
Withdrawal of blood samples for FibrinogenDiagnostic 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.
Echocardiographic ExaminationDiagnostic 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 | Role | What they receive |
|---|---|---|
| Study Group | Premature newborns born before 32nd gestational week and weighing less than 1500 grams. Receives: Diagnostic Test: Withdrawal of blood samples for D-Dimer; Diagnostic Test: Withdrawal of blood samples for Fibrinogen; Diagnostic Test: Echocardiographic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: postnatal 0 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start14 Mar 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ductus Arteriosus, PatentStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
- Investigators
- Hasan Tolga Çelik, Study chair, Hacettepe UniversityAlper Aykanat, Principal investigator, Hacettepe Universityİlker Ertuğrul, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508036
- Sponsor's protocol ID
- KA-19033
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12632021Sehgal 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.
PubMed 23052621
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels in Premature Babies
- ClinicalTrials.gov ID
- NCT04508036
- Acronym / sponsor ID
- KA-19033
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- Premature Newborn, Ductus Arteriosus, D-Dimer, Fibrinogen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ductus arteriosus (DA) is located between the main pulmonary artery and descending aorta in embryonal life, with dense spiral-located smooth muscle cells in the media layer, and the intima layer is thicker than the aorta. It must be open in fetal life; in this way, the blood flowing from the right ventricle to the collapsed lungs is directed to the descending aorta. DA usually closes "functionally" by constriction of the media during the first three days after labor. In the second week after birth; endothelial folding, subendothelial proliferation and coagulation processes results in "anatomical" permanent closure.
When not closed, patent ductus arteriosus (PDA) is formed resulting in shunting from aorta to pulmonary artery. Probability of patency is inversely related with birth weight. Risk of pulmonary edema, pulmonary hemorrhage, bronchopulmonary dysplasia and loss of pulmonary function increases due to increased pulmonary flow from left to right shunt. Renal, mesenteric and cranial blood supply are impaired due to reduced peripheral circulation. As a result, impaired renal function and necrotizing enterocolitis may develop. Risk of intracranial hemorrhage, cerebral hypoxia and premature retinopathy due to variable blood supply. It has been associated with increased mortality in newborns due to increased morbidity. On physical examination, hyperdynamic precordium, viable pulses and left ventricular hypertrophy are observed. Large PDAs are characterized by prominent pulmonary conus, increased pulmonary vascularization and cardiomegaly on telecardiography.
Diagnosis of PDA is confirmed by echocardiography. Symptomatic PDA treatment and follow-up is mostly followed by echocardiography. Detailed echocardiographic examination can only be performed by a Pediatric Cardiologist, but it is not possible to evaluate DA at any time. It is necessary to benefit from significant changes in specific hematological parameters that may accompany DA closure in order to detect and predict these conditions.
One of the main mechanisms involved in anatomic permanent closure in DA is platelet aggregation and coagulation. To the best of our knowledge, there is no study in the literature investigating whether there is a relationship between Fibrinogen and D-dimer levels and anatomical closure of DA. It is postulated that circulating fibrinogen levels will decrease and D-dimer levels increase as a by-product due to thrombosis in the lumen during DA closure. It is predicted that in infants in whom DA does not close and remain open, fibrinogen levels will be higher and D-dimer levels will be lower than infants in whom DA is closed. It is also suggested that echocardiographic DA measurements will correlate with serum Fibrinogen and D-Dimer levels.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Withdrawal of blood samples for D-Dimer, Diagnostic Test: Withdrawal of blood samples for Fibrinogen, Diagnostic Test: Echocardiographic ExaminationPremature newborns born before 32nd gestational week and weighing less than 1500 grams. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- otherwise healthy premature newborns born before 32nd gestational week and weighing less than 1500 grams.
Key inclusion criteria (1 listed)
- premature newborns born before 32nd gestational week and weighing less than 1500 grams.
Key exclusion criteria (10 listed)
- Major congenital anomalies
- Chromosomal anomalies
- Inborn errors of metabolism
- Hypoxic ischemic encephalopathy
- Disseminated intravascular coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of blood samples for D-DimerBlood 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. | Diagnostic test | Study Group |
| Withdrawal of blood samples for FibrinogenBlood 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. | Diagnostic test | Study Group |
| Echocardiographic ExaminationAt postnatal 3rd, 7th and 14th days, Ductus Arteriosus will be echocardiographically examined to obtain calculations and confirm status of ductal patency or closure. | Diagnostic test | Study Group |
Primary outcome
Rise in D-dimer blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days
Time frame: postnatal 0 - 14 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.
Fall in Fibrinogen blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days
Time frame: postnatal 0 - 14 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 12632021Tay 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.
- Background: PubMed 23052621Sehgal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Tolga Çelik study chair
Hacettepe University
Alper Aykanat principal investigator
Hacettepe University
İlker Ertuğrul principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ductus Arteriosus, Patent, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Tolga Çelik (+90 530 592 55 84, htcelik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rise in D-dimer blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days (time frame: postnatal 0 - 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.