Patent Ductus Arteriosus After Premature BirthNCT05686343
Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks
An observational study of Patent Ductus Arteriosus After Premature Birth, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA. Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Patent Ductus Arteriosus After Premature Birth
- What is being tested?
- Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jul 2023
- How long will I take part?
- 2 Years
- 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 1 minute to 7 days
- All sexes
- Child
Study population: Newborns < 32 weeks
Who may be able to join
- Born at less than 32 weeks newborns
Who cannot join
- Congenital heart disease
- Syndromic and/or major congenital anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özlem Bayram
Ankara, 06100
Özlem Bayram, 05058192105, drbayram.ozlem@gmail.com
About this study
Official title: Hemodynamically Important PDA in Newborns Under 32 Weeks: Clinical and Echocardiographic Findings and Outcomes
To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.
- Being tested
- Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy
- Keywords
- Cardiology, Newborn, Diseases, Congenital Heart Defects, Patent Ductus Arteriosus
- Medical subject headings
- Disease, Heart Defects, Congenital, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography, Doppler ultrasonography, Near-infrared spectroscopyDiagnostic test
Ecocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life
| Study group | Role | What they receive |
|---|---|---|
| Treated | Not described Receives: Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy | |
| Untreated | Not described Receives: Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of PDA
Measurement the diameter of ductus in mm/weight using echocardiography
Measured: 1 year
Velosity of PDA
Measurement the velosity of ductus using CW doppler on ecocardiyograpy
Measured: 1 year
Left ventricule expansion
Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography
Measured: 1 year
Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries
Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jul 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus After Premature BirthStudies of the same condition, open and under way.
- More trials run by Ankara 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
- 70 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Bayram, Ankara University
- Investigators
- Özlem Bayram, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686343
- Sponsor's protocol ID
- Ankara University-001
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamically Important PDA in Newborns Under 32 Weeks: Clinical and Echocardiographic Findings and Outcomes
- ClinicalTrials.gov ID
- NCT05686343
- Acronym / sponsor ID
- Ankara University-001
- Keywords
- Cardiology, Newborn, Diseases, Congenital Heart Defects, Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | – | Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy |
| Untreated | – | Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Age groups
- Child
- Study population
- Newborns < 32 weeks
Key inclusion criteria (1 listed)
- Born at less than 32 weeks newborns
Key exclusion criteria (2 listed)
- Congenital heart disease
- Syndromic and/or major congenital anomaly
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 |
|---|---|---|
| Echocardiography, Doppler ultrasonography, Near-infrared spectroscopyEcocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life | Diagnostic test | Treated, Untreated |
Primary outcome
Diameter of PDA
Time frame: 1 year
Measurement the diameter of ductus in mm/weight using echocardiography
Velosity of PDA
Time frame: 1 year
Measurement the velosity of ductus using CW doppler on ecocardiyograpy
Left ventricule expansion
Time frame: 1 year
Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography
Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries
Time frame: 1 year
Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Özlem Bayram principal investigator
Ankara 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 Patent Ductus Arteriosus After Premature Birth, run by Ankara 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 2 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 17 Jan 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 Özlem Bayram (05058192105, drbayram.ozlem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of PDA (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.