Article Text

Download PDFPDF
Dealing with the unknown: reducing the proportion of unvalidated treatments offered to children

Statistics from Altmetric.com

Footnotes

  • Twitter Follow Dominic Wilkinson at @NeonatalEthics

  • Contributors DW conceived of the paper and wrote an initial draft. IC, MC and WTM commented on drafts of the manuscript, edited the paper, and approved the final version for publication.

  • Funding DW was supported for this work by a grant from the Wellcome trust, [086041/Z/08/Z]. The funders had no role in the design or conduct of this study, collection, management or analysis of data, nor in preparation, review or approval of this manuscript.

  • Competing interests WTM was a chief investigator on the Australian and New Zealand BOOST II oxygen saturation targeting trials and many other neonatal randomised controlled trials. IC chaired the data safety monitoring committee for the UK BOOST II trial.

  • Provenance and peer review Commissioned; externally peer reviewed.

  • i However, as OHRP noted, the trial information leaflet appropriately disclosed (29 May 2008 version, p.5) that the CPAP (Continuous Positive Airways Pressure) or intubation or surfactant arm of this randomised 2×2 factorial trial carried a risk of resuscitation, chest compressions and even death. Every parent was thus informed, before random allocation of treatments, that the SUPPORT trial entailed this risk.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles

  • Fantoms
    Martin Ward Platt