Evidence map›Paper›PMID 34526095›Full record

Trial reportTrials2021

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.

Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M W Kooi, Daniel C Vijlbrief, Willem B de Vries, Debbie H G M Nuytemans, Bart van Overmeire, Antonius L Mulder, Willem P de Boode and 1 more

Registry-linked trialOpen access · goldAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02884219 (Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02884219 nacompletednot on this map

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)

TypeinterventionalSponsorRadboud University Medical CenterRan2016 to 2022Enrolled273ConditionsPatent Ductus ArteriosusArmsIbuprofen, Expectative Management, Indomethacin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 2 countries.

Tim HundscheidRadboud Institute for Health Sciences, Amalia Children's Hospital, Department of Paediatrics, Division of Neonatology, Radboud University Medical Centre Nijmegen, Internal postal code 804, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. tim.hundscheid@radboudumc.nl.ORCID http://orcid.org/0000-0002-5143-2845
Rogier DondersDepartment for Health Evidence, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.
Wes OnlandEmma Children's Hospital Amsterdam University Medical Centers, Department of Neonatology, University of Amsterdam, Vrije Universiteit Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Elisabeth M W KooiBeatrix Children's Hospital, Department of Paediatrics, Division of Neonatology, University Medical Center Groningen, Hanzeplein 1, 9713, GZ, Groningen, The Netherlands.
Daniel C VijlbriefUtrecht University, Wilhelmina Children's Hospital, Division of Woman and Baby, Department of Neonatology, University Medical Centre Utrecht, Lundlaan 6, 3584, EA, Utrecht, The Netherlands.
Willem B de VriesWilhelmina Children's Hospital, Division of Woman and Baby, Department of Neonatology, University Medical Centre Utrecht, Utrecht University, Lundlaan 6, 3584, EA, Utrecht, The Netherlands.
Debbie H G M NuytemansNeonatology Network Netherlands (N3), p/a Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Bart van OvermeireOpgroeien, Flemish Government, Brussels, Belgium.
Antonius L MulderDepartment of Paediatrics, Division of Neonatology, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
Willem P de BoodeRadboud Institute for Health Sciences, Amalia Children's Hospital, Department of Paediatrics, Division of Neonatology, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.
BeNeDuctus trial study group
Radboud University Nijmegen · NLUtrecht University · NLAntwerp University Hospital · BEEmma Kinderziekenhuis · NLFlemish Government · BEUniversity Medical Center Groningen · NL

Funding

ZonMw 843002622
6 · The paper itself

Abstract

backgroundControversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. METHODS/

designThe BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24-72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data.

trial registrationClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.

Indexed as

Ductus Arteriosus, PatentChild, PreschoolHumansIbuprofenInfantInfant, Low Birth WeightInfant, NewbornInfant, PrematureWatchful WaitingIbuprofenBronchopulmonary dysplasiaDuctal ligationExpectant managementIbuprofenMortalityNecrotising enterocolitisNeonatal intensive care unitPatent ductus arteriosusPrematurityStatistical analysis plan

Identifiers

PMID34526095
PMCPMC8444433
OpenAlexW3201335815

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.