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Early Treatment Versus Expectative Management of PDA in Preterm Infants (BeNeDuctus)

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ClinicalTrials.gov Identifier: NCT02884219
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Ibuprofen Other: Expectative Management Drug: Indomethacin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 23, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early Treatment with cyclooxygenase inhibitors
Treatment of PDA that starts within the first 3 days of life using cyclooxygenase-inhibitors (Ibuprofen or Indomethacin)
Drug: Ibuprofen
In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
Other Name: Cyclooxygenase Inhibitor

Drug: Indomethacin
In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
Other Name: Cyclooxygenase Inhibitor

Sham Comparator: Expectative Treatment
Expectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
Other: Expectative Management
Expectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
Other Name: Conservative management




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Short term sequelae of cardiovascular failure [ Time Frame: Day 1 up to 3 months ]
    At the time of discharge the incidence of cardiovascular failure is calculated

  2. Short term sequelae of adverse events [ Time Frame: Day 1 up to 3 months ]
    At the time of discharge the number of all adverse events are calculated

  3. Long-term neurodevelopmental consequences assessed with BSID-III-NL. [ Time Frame: Assessed at an corrected age of 2 years ]
    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).



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884219


Contacts
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Contact: Willem P de Boode, MD PhD +31 24 361 44 30 willem.deboode@radboudumc.nl

Locations
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Belgium
University Hospital Antwerp Not yet recruiting
Antwerp, Belgium
Contact: David van Laere, MD PhD         
Hôpital Erasme - Clinique Universitaires de Bruxelles Not yet recruiting
Brussels, Belgium
Contact: Bart van Overmeire, Prof         
University Hospital Brussels Not yet recruiting
Brussels, Belgium
Contact: Filip Cools, Prof         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: Wes Onland, MD PhD         
Free University Amsterdam Not yet recruiting
Amsterdam, Netherlands
Contact: Harry Lafeber, Prof.dr.         
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands
Contact: Elisabeth Kooi, MD PhD         
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Remco Visser, MD PhD         
Maatricht University Medical Center Not yet recruiting
Maastricht, Netherlands
Contact: Eduardo Villamor, MD PhD         
Radboudumc Amalia Children's Hospital Recruiting
Nijmegen, Netherlands
Contact: Willem de Boode, MD PhD         
Erasmus Medical Center Rotterdam Not yet recruiting
Rotterdam, Netherlands
Contact: Johan de Klerk, MD PhD         
Wilhelmina Children's Hospital/UMCU Not yet recruiting
Utrecht, Netherlands
Contact: Daniël Vijlbrief, MD PhD         
Maxima Medical Center Not yet recruiting
Veldhoven, Netherlands
Contact: Koen Dijkman, MD PhD         
Isala Kliniek Zwolle Not yet recruiting
Zwolle, Netherlands
Contact: S. de Tollenaer, MD PhD         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Willem P de Boode, MD PhD Radboud University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02884219    
Other Study ID Numbers: 843002622
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be made available after an embargo period

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Early treatment
Expectative treatment
Patent ductus arteriosus
Preterm
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Indomethacin
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents