Patent Ductus ArteriosusBeNeDuctusNCT02884219
Early Treatment Versus Expectative Management of PDA in Preterm Infants
A study testing Ibuprofen, Expectative Management and Indomethacin in people with Patent Ductus Arteriosus, run by Radboud University Medical Center at 13 sites in 2 countries.
Trial summary
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Ibuprofen, Expectative Management and Indomethacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 23 Dec 2016to 15 Mar 2022
- Phase
- Interventional
- 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 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- Signed informed consent obtained from parent(s) or representative(s)
- Gestational age < 28 completed weeks
Who cannot join
- Contraindication for administration of cyclooxygenase-inhibitors (COXi)
- Persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle)
- Congenital heart defect, other than PDA and/or patent foramen ovale (PFO)
- Life-threatening congenital defects
- Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome
- Use of COXi prior to randomization
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Netherlands10 sites
Academic Medical Center
Amsterdam
Free University Amsterdam
Amsterdam
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden
Maatricht University Medical Center
Maastricht
Radboudumc Amalia Children's Hospital
Nijmegen
Erasmus Medical Center Rotterdam
Rotterdam
Wilhelmina Children's Hospital/UMCU
Utrecht
Maxima Medical Center
Veldhoven
Isala Kliniek Zwolle
Zwolle
Belgium3 sites
University Hospital Antwerp
Antwerp
Hôpital Erasme - Clinique Universitaires de Bruxelles
Brussels
University Hospital Brussels
Brussels
About this study
Official title: Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants (BeNeDuctus Trial - Belgium Netherlands Ductus Trial)
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing.
The objective of this study is to investigate whether in preterm infants <28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.
Read the detailed description
After obtainment of informed consent the first echocardiographic evaluation is performed at a postnatal age of 24-72 hours. In absence of exclusion criteria patients will only be randomized when a PDA is present, the transductal diameter measures >1.5 mm and a blood flow pattern with a predominantly left-to-right shunt is observed. Randomization will assign the neonate to either the medical treatment (COXi) arm or the expectative PDA management arm.
It is essential that neonatal management is similar in both arms with the exception of the prescription of COX-inhibition and routine echocardiographic examination after a course of COXi in the medical treatment arm.
Medical treatment arm When the patient is allocated to the medical treatment arm COX-inhibition is prescribed and started as soon as possible, but no later than 3 hours after the echocardiogram.
The investigators prefer to use Ibuprofen (IBU) for COX-inhibition in this study. Aside from the above mentioned reasons the investigators are confronted with an actual lack of availability of indomethacin in most centers in the Netherlands and Belgium. However, Indomethacin (INDO) can be prescribed for medical ductal closure if this is preferred by a participating center.
The dosing schemes for IBU and INDO are according the local guidelines. For the first week of life the birth weight is used for calculation of the COXi dosage. After a postnatal age of 7 days the actual weight is used for dose calculation, except when the actual weight is still less than the birthweight.
The treatment described above is considered standard of care in many NICU's worldwide. It should be noted that there is no modification of the commonly advised usage of IBU in this study. There are reports that suggest that an high dose of IBU might be more effective in ductal closure in preterm infants, especially in those less than 27 weeks' gestation. However, in a systematic review one refrained from recommendations regarding high dose IBU because of the limited number of patients enrolled in studies.
The preferred route of administration of IBU is intravenously. However, this is at the disposal of the attending physician, since enteral administration appears at least as effective.
Echocardiographic reevaluation is performed at least 12 hours after the last (3rd) dose of the first COXi course. If the ductus arteriosus is found to be closed, no further analysis or treatment is needed regarding the ductus arteriosus. A ductus arteriosus is considered to be closed when it can't be visualized using color Doppler imaging or when the transductal diameter measures less than 0.5 mm.
When the ductus arteriosus hasn't closed, a second course of COX-inhibition is started at least 24 hours after the third dose of the first course. COXi dosages are similar to the first course.
Twelve to 24 hours after the last dose of the second course (6th gift) echocardiography is performed. If the ductus arteriosus is found to be closed, no further analysis or treatment is needed regarding the ductus arteriosus.
When the duct failed to close after two courses of COXi (6 doses in total) and the PDA is judged to be still hemodynamically significant, ductal ligation can be considered, only when the so-called 'ligation criteria' are met.
Expectative PDA management arm Patients randomized to the expectative management arm will not receive any COXi and PDA management in this group can be characterized as "watchful waiting". This is not a unique approach, since a restrictive approach towards a PDA is increasingly used in many centers worldwide without the observation of an increased risk of neonatal mortality and morbidity, such as severe chronic lung disease (CLD), intraventricular hemorrhage (IVH), NEC and retinopathy of prematurity (ROP).
It is essential that neonatal management is similar in both study arms with the exception of the prescription of COXi and echocardiography at the end of the drug course in the medical treatment arm. It is of the upmost importance that NO extra interventions are to be undertaken with the intention to conservatively prevent or treat a (suspected) PDA in the expectative arm, such as fluid restriction and diuretics for that reason. Moreover, it should be noted that there is insufficient evidence that fluid restriction and/or diuretics are of any benefit in patients with a (suspected) PDA.
When during the first week the attending physician is of the opinion that the patient is in danger, when it's deprived from treatment with COXi, open label treatment can only be considered when the 'open label criteria' are met.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Ibuprofen, Expectative Management, Indomethacin
- Keywords
- Early treatment, Expectative treatment, Patent ductus arteriosus, Preterm
- 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.
IbuprofenDrug
Also called Cyclooxygenase Inhibitor
In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
Expectative ManagementOther
Also called Conservative management
Expectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
IndomethacinDrug
Also called Cyclooxygenase Inhibitor
In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment with cyclooxygenase inhibitors | Active comparator | Treatment of PDA that starts within the first 3 days of life using cyclooxygenase-inhibitors (Ibuprofen or Indomethacin) Receives: Drug: Ibuprofen; Drug: Indomethacin |
| Expectative Treatment | Sham comparator | Expectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA. Receives: Other: Expectative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of mortality, and/or NEC, and/or BPD
The primary outcome is the composite of mortality, and/or NEC (Bell stage ≥ IIa), and/or BPD, defined as the need for supplemental oxygen need, all at a postmenstrual age of 36 completed weeks.
Measured: At a postmenstrual age of 36 completed weeks
Secondary outcomes (3)
Short term sequelae of cardiovascular failure
At the time of discharge the incidence of cardiovascular failure is calculated
Measured: Day 1 up to 3 months
Short term sequelae of adverse events
At the time of discharge the number of all adverse events are calculated
Measured: Day 1 up to 3 months
Long-term neurodevelopmental consequences assessed with BSID-III-NL.
All patients in this study will be included in the National Neonatal Follow Up Program and are therefore seen at a corrected age of 24 months. Their neurodevelopment is assessed with the Bayley Scales of Infant and Toddler Development, Third Dutch Edition (BSID-III-NL).
Measured: Assessed at an corrected age of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start23 Dec 2016
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Willem P de Boode, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884219
- Sponsor's protocol ID
- 843002622
- Acronym
- BeNeDuctus
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2016
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available after an embargo period
Publications
Hundscheid T, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Dijkman KP, van Kaam AH, Villamor E, Kroon AA, Visser R, Mulder-de Tollenaer SM, De Bisschop B, Dijk PH, Avino D, Hocq C, Zecic A, Meeus M, de Baat T, Derriks F, Henriksen TB, Kyng KJ, Donders R, Nuytemans DHGM, Van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med. 2023 Mar 16;388(11):980-990. doi: 10.1056/NEJMoa2207418. Epub 2022 Dec 6.
PubMed 36477458Apers WMJ, Hundscheid T, Kooi EMW, Onland W, Vijlbrief D, Steiner K, Donders R, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Long-Term Outcomes of Expectant Management versus Early Ibuprofen for Patent Ductus Arteriosus: 24-Month Follow-Up of the BeNeDuctus Trial. J Pediatr. 2026 Sep 17;299:115292. doi: 10.1016/j.jpeds.2026.115292. Online ahead of print.
PubMed 42637114Hundscheid T, Donders R, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Nuytemans DHGM, van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus trial study group. Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan. Trials. 2021 Sep 15;22(1):627. doi: 10.1186/s13063-021-05594-x.
PubMed 34526095Hundscheid T, Onland W, van Overmeire B, Dijk P, van Kaam AHLC, Dijkman KP, Kooi EMW, Villamor E, Kroon AA, Visser R, Vijlbrief DC, de Tollenaer SM, Cools F, van Laere D, Johansson AB, Hocq C, Zecic A, Adang E, Donders R, de Vries W, van Heijst AFJ, de Boode WP. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial). BMC Pediatr. 2018 Aug 4;18(1):262. doi: 10.1186/s12887-018-1215-7.
PubMed 30077184
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants (BeNeDuctus Trial - Belgium Netherlands Ductus Trial)
- ClinicalTrials.gov ID
- NCT02884219
- Acronym / sponsor ID
- BeNeDuctus / 843002622
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Early treatment, Expectative treatment, Patent ductus arteriosus, Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 30 Aug 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.
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing.
The objective of this study is to investigate whether in preterm infants <28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.
Detailed description
After obtainment of informed consent the first echocardiographic evaluation is performed at a postnatal age of 24-72 hours. In absence of exclusion criteria patients will only be randomized when a PDA is present, the transductal diameter measures >1.5 mm and a blood flow pattern with a predominantly left-to-right shunt is observed. Randomization will assign the neonate to either the medical treatment (COXi) arm or the expectative PDA management arm.
It is essential that neonatal management is similar in both arms with the exception of the prescription of COX-inhibition and routine echocardiographic examination after a course of COXi in the medical treatment arm.
Medical treatment arm When the patient is allocated to the medical treatment arm COX-inhibition is prescribed and started as soon as possible, but no later than 3 hours after the echocardiogram.
The investigators prefer to use Ibuprofen (IBU) for COX-inhibition in this study. Aside from the above mentioned reasons the investigators are confronted with an actual lack of availability of indomethacin in most centers in the Netherlands and Belgium. However, Indomethacin (INDO) can be prescribed for medical ductal closure if this is preferred by a participating center.
The dosing schemes for IBU and INDO are according the local guidelines. For the first week of life the birth weight is used for calculation of the COXi dosage. After a postnatal age of 7 days the actual weight is used for dose calculation, except when the actual weight is still less than the birthweight.
The treatment described above is considered standard of care in many NICU's worldwide. It should be noted that there is no modification of the commonly advised usage of IBU in this study. There are reports that suggest that an high dose of IBU might be more effective in ductal closure in preterm infants, especially in those less than 27 weeks' gestation. However, in a systematic review one refrained from recommendations regarding high dose IBU because of the limited number of patients enrolled in studies.
The preferred route of administration of IBU is intravenously. However, this is at the disposal of the attending physician, since enteral administration appears at least as effective.
Echocardiographic reevaluation is performed at least 12 hours after the last (3rd) dose of the first COXi course. If the ductus arteriosus is found to be closed, no further analysis or treatment is needed regarding the ductus arteriosus. A ductus arteriosus is considered to be closed when it can't be visualized using color Doppler imaging or when the transductal diameter measures less than 0.5 mm.
When the ductus arteriosus hasn't closed, a second course of COX-inhibition is started at least 24 hours after the third dose of the first course. COXi dosages are similar to the first course.
Twelve to 24 hours after the last dose of the second course (6th gift) echocardiography is performed. If the ductus arteriosus is found to be closed, no further analysis or treatment is needed regarding the ductus arteriosus.
When the duct failed to close after two courses of COXi (6 doses in total) and the PDA is judged to be still hemodynamically significant, ductal ligation can be considered, only when the so-called 'ligation criteria' are met.
Expectative PDA management arm Patients randomized to the expectative management arm will not receive any COXi and PDA management in this group can be characterized as "watchful waiting". This is not a unique approach, since a restrictive approach towards a PDA is increasingly used in many centers worldwide without the observation of an increased risk of neonatal mortality and morbidity, such as severe chronic lung disease (CLD), intraventricular hemorrhage (IVH), NEC and retinopathy of prematurity (ROP).
It is essential that neonatal management is similar in both study arms with the exception of the prescription of COXi and echocardiography at the end of the drug course in the medical treatment arm. It is of the upmost importance that NO extra interventions are to be undertaken with the intention to conservatively prevent or treat a (suspected) PDA in the expectative arm, such as fluid restriction and diuretics for that reason. Moreover, it should be noted that there is insufficient evidence that fluid restriction and/or diuretics are of any benefit in patients with a (suspected) PDA.
When during the first week the attending physician is of the opinion that the patient is in danger, when it's deprived from treatment with COXi, open label treatment can only be considered when the 'open label criteria' are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Treatment with cyclooxygenase inhibitors | Active comparator | Drug: Ibuprofen, Drug: IndomethacinTreatment of PDA that starts within the first 3 days of life using cyclooxygenase-inhibitors (Ibuprofen or Indomethacin) |
| Expectative Treatment | Sham comparator | Other: Expectative ManagementExpectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA. |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- Signed informed consent obtained from parent(s) or representative(s)
- Gestational age < 28 completed weeks
Key exclusion criteria (6 listed)
- Contraindication for administration of cyclooxygenase-inhibitors (COXi)
- Persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle)
- Congenital heart defect, other than PDA and/or patent foramen ovale (PFO)
- Life-threatening congenital defects
- Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome
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 |
|---|---|---|
| IbuprofenAlso: Cyclooxygenase InhibitorIn the medical treatment (COXi) arm the intention is to close the ductus arteriosus. | Drug | Early Treatment with cyclooxygenase inhibitors |
| Expectative ManagementAlso: Conservative managementExpectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA. | Other | Expectative Treatment |
| IndomethacinAlso: Cyclooxygenase InhibitorIn the medical treatment (COXi) arm the intention is to close the ductus arteriosus. | Drug | Early Treatment with cyclooxygenase inhibitors |
Primary outcome
Composite of mortality, and/or NEC, and/or BPD
Time frame: At a postmenstrual age of 36 completed weeks
The primary outcome is the composite of mortality, and/or NEC (Bell stage ≥ IIa), and/or BPD, defined as the need for supplemental oxygen need, all at a postmenstrual age of 36 completed weeks.
3 secondary outcomes
Short term sequelae of cardiovascular failure
Time frame: Day 1 up to 3 months
Short term sequelae of adverse events
Time frame: Day 1 up to 3 months
Long-term neurodevelopmental consequences assessed with BSID-III-NL.
Time frame: Assessed at an corrected age of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 36477458Hundscheid T, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Dijkman KP, van Kaam AH, Villamor E, Kroon AA, Visser R, Mulder-de Tollenaer SM, De Bisschop B, Dijk PH, Avino D, Hocq C, Zecic A, Meeus M, de Baat T, Derriks F, Henriksen TB, Kyng KJ, Donders R, Nuytemans DHGM, Van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med. 2023 Mar 16;388(11):980-990. doi: 10.1056/NEJMoa2207418. Epub 2022 Dec 6.
- Derived from this study: PubMed 42637114Apers WMJ, Hundscheid T, Kooi EMW, Onland W, Vijlbrief D, Steiner K, Donders R, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Long-Term Outcomes of Expectant Management versus Early Ibuprofen for Patent Ductus Arteriosus: 24-Month Follow-Up of the BeNeDuctus Trial. J Pediatr. 2026 Sep 17;299:115292. doi: 10.1016/j.jpeds.2026.115292. Online ahead of print.
- Derived from this study: PubMed 34526095Hundscheid T, Donders R, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Nuytemans DHGM, van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus trial study group. Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan. Trials. 2021 Sep 15;22(1):627. doi: 10.1186/s13063-021-05594-x.
- Derived from this study: PubMed 30077184Hundscheid T, Onland W, van Overmeire B, Dijk P, van Kaam AHLC, Dijkman KP, Kooi EMW, Villamor E, Kroon AA, Visser R, Vijlbrief DC, de Tollenaer SM, Cools F, van Laere D, Johansson AB, Hocq C, Zecic A, Adang E, Donders R, de Vries W, van Heijst AFJ, de Boode WP. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial). BMC Pediatr. 2018 Aug 4;18(1):262. doi: 10.1186/s12887-018-1215-7.
- Website BeNeDuctus TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be made available after an embargo period
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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.
Willem P de Boode, MD PhD principal investigator
Radboud University Medical Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen, Expectative Management and Indomethacin in people with Patent Ductus Arteriosus, run by Radboud University Medical Center at 13 sites in 2 countries.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Belgium. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of mortality, and/or NEC, and/or BPD (time frame: At a postmenstrual age of 36 completed weeks). 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 NCT02884219, which also lists 4 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 3 Jul 2023.