University of Leicester
Browse
Gupta et al_BABYOscarProtocol_BMCPeds_2021.pdf (1.43 MB)

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

Download (1.43 MB)
journal contribution
posted on 2021-03-08, 11:27 authored by Samir Gupta, Edmund Juszczak, Pollyanna Hardy, Nimish Subhedar, Jonathan Wyllie, Wilf Kelsall, Sunil Sinha, Sam Johnson, Tracy Roberts, Elisabeth Hutchison, Justine Pepperell, Louise Linsell, Jennifer L Bell, Kayleigh Stanbury, Marketa Laube, Clare Edwards, David Field
Background
The 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.

Methods
This 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+ 0–28+ 6 weeks’ gestation) improves short and long-term health and economic outcomes. With parental informed consent, extremely preterm babies (born between 23+ 0–28+ 6 weeks’ gestation) admitted to tertiary neonatal units are screened using echocardiography. Babies with a large PDA on echocardiography, defined by diameter of at least 1.5 mm and unrestricted pulsatile PDA flow pattern, are randomly allocated to either ibuprofen or placebo within 72 h of birth. The primary endpoint is the composite outcome of death by 36 weeks’ postmenstrual age or moderate or severe bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age.

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.

History

Citation

BMC Pediatr 21, 100 (2021). https://doi.org/10.1186/s12887-021-02558-7

Author affiliation

Department of Health Sciences, University of Leicester

Version

  • VoR (Version of Record)

Published in

BMC Pediatrics

Volume

21

Issue

1

Publisher

Springer Science and Business Media LLC

eissn

1471-2431

Acceptance date

2021-02-15

Copyright date

2021

Available date

2021-02-26

Language

en

Usage metrics

    University of Leicester Publications

    Categories

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC