Patent Ductus ArteriosusNCT02910609
International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial
An observational study of Patent Ductus Arteriosus, run by Ankara University.
Trial summary
The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- How long will I take part?
- 3 Months
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at 24 0/7-28 6/7 gestation weeks' who were performed echocardiography at or after postnatal 72 hours of life, and detected ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 are the candidates for the study. The management of PDA and the other data of these infants will be registered to online registry system.
Who may be able to join
- Infants born at 24 0/7-28 6/7 gestation weeks'
- PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life
Who cannot join
- Infants died before 72 hours of life
- Infants detected PDA but treated before 72 hours of life
Trial locations and contacts
No sites are listed yet.
About this study
Official title: International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial
The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.
Read the detailed description
Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.
In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.
Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.
Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Echocardiography
- Keywords
- preterm, patent ductus arterioles, treatment
- 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.
EchocardiographyDevice
Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Management at PN 3-7 days | Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life Receives: Device: Echocardiography | |
| Management after PN 7 days | Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontan closure rate
Rate of patients with spontaneous ductal closure
Measured: 3 months
Secondary outcomes (2)
Surgical ligation rate
rate of patients who need surgical ligation for hemodynamically significant ductus
Measured: 3 months
Complications of prematurity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies 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
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Erdeve, Ankara University
- Investigators
- Ömer Erdeve, Professor, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910609
- Sponsor's protocol ID
- Ankara University
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data individual data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial
- ClinicalTrials.gov ID
- NCT02910609
- Acronym / sponsor ID
- Ankara University
- Conditions
- Patent Ductus Arteriosus
- Keywords
- preterm, patent ductus arterioles, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- 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 three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.
Detailed description
Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.
In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.
Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.
Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Management at PN 3-7 days | – | Device: EchocardiographyPreterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life |
| Management after PN 7 days | – | Device: EchocardiographyPreterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at 24 0/7-28 6/7 gestation weeks' who were performed echocardiography at or after postnatal 72 hours of life, and detected ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 are the candidates for the study. The management of PDA and the other data of these infants will be registered to online registry system.
Key inclusion criteria (2 listed)
- Infants born at 24 0/7-28 6/7 gestation weeks'
- PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life
Key exclusion criteria (2 listed)
- Infants died before 72 hours of life
- Infants detected PDA but treated before 72 hours of life
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 |
|---|---|---|
| EchocardiographyEchocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups. | Device | Management after PN 7 days, Management at PN 3-7 days |
Primary outcome
Spontan closure rate
Time frame: 3 months
Rate of patients with spontaneous ductal closure
2 secondary outcomes
Surgical ligation rate
Time frame: 3 months
Complications of prematurity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Individual participant dataSharing planned: No. No data individual data will be shared
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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.
Ömer Erdeve, Professor principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Ankara University.
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 2 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Ömer Erdeve, Professor (+90-505-4812151, omererdeve@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontan closure rate (time frame: 3 months). 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 22 Sep 2016.