Evidence map›Paper›PMID 33637074›Full record

ArticleBMC pediatrics2021

Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

Samir Gupta, Edmund Juszczak, Pollyanna Hardy, Nimish Subhedar, Jonathan Wyllie, Wilf Kelsall, Sunil Sinha, Sam Johnson, Tracy Roberts, Elisabeth Hutchison and 8 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
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  8. Recent research on the effect of common treatments given in the perinatal period on neurodevelopment in offspring.Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2022
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 1 country.

Samir GuptaUniversity Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, UK. samir.gupta@durham.ac.uk.
Edmund JuszczakNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Pollyanna HardyNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Nimish SubhedarLiverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK.
Jonathan WyllieSouth Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, TS4 3BW, UK.
Wilf KelsallNICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge, CB2 2QQ, UK.
Sunil SinhaSouth Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, TS4 3BW, UK.
Sam JohnsonThe University of Leicester, Department of Health Science, University Road, George Davies Centre, Leicester, LE1 7RH, UK.
Tracy RobertsInstitute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Elisabeth HutchisonNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Justine PepperellNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Louise LinsellNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Jennifer L BellNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Kayleigh StanburyNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Marketa LaubeNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Clare EdwardsNational Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
David FieldThe University of Leicester, Department of Health Science, University Road, George Davies Centre, Leicester, LE1 7RH, UK.
‘The Baby-OSCAR Collaborative Group’
University of Oxford · GBJames Cook University Hospital · GBUniversity of Birmingham · GBUniversity of Leicester · GBLiverpool Womens NHS Foundation Trust · GBRosie Hospital · GBUniversity Hospital of North Tees · GB

Funding

Health Technology Assessment Programme 11/92/15
6 · The paper itself

Abstract

backgroundThe question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks' gestation are born in the UK every year. In 40% of cases the PDA will fail to close spontaneously, even by 4 months of age. Untreated PDA can be associated with several serious and life-threatening short and long-term complications. Reliable data to support clinical decisions about PDA treatment are needed to prevent serious complications in high risk babies, while minimising undue exposure of infants. With the availability of routine bedside echocardiography, babies with a large PDA can be diagnosed before they become symptomatic.

methodsThis is a multicentre, masked, randomised, placebo-controlled parallel group trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies (23 DISCUSSION: Prophylactic pharmacological treatment of all preterm babies unnecessarily exposes them to potentially serious side effects of drug treatment, when their PDA may have closed spontaneously. However, delaying treatment until babies become symptomatic could result in loss of treatment benefit as irreversible damage may have already been done. Targeted, early pharmacological treatment of PDA in asymptomatic babies has the potential to overcome the disadvantages of both prophylactic (overtreatment) and symptomatic approaches (potentially too late). This could result in improvements in the clinically important short-term clinical (mortality and moderate or severe BPD at 36 weeks' postmenstrual age) and long-term health outcomes (moderate or severe neurodevelopment disability and respiratory morbidity) measured at 2 years corrected age.

trial registrationISRCTN84264977 . Date assigned: 15/09/2010.

Indexed as

Bronchopulmonary DysplasiaDuctus Arteriosus, PatentInfant, Premature, DiseasesHumansIbuprofenInfantInfant, Low Birth WeightInfant, NewbornMulticenter Studies as TopicRandomized Controlled Trials as TopicIbuprofenBronchopulmonary dysplasiaEchocardiographyIbuprofenNewbornPatent ductus arteriosusPDAPreterm

Identifiers

PMID33637074
PMCPMC7908699
OpenAlexW3131829679

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.