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The BRACELET study: implications for the design of randomised controlled trials in neonatal and paediatric intensive care
  1. Nicholas D Embleton1,2,
  2. Judith Rankin2
  1. 1 Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  2. 2 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
  1. Correspondence to Dr Nicholas D Embleton, Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UK; nicholas.embleton{at}ncl.ac.uk

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Research is essential to improving care and outcomes, but presents challenges when infants and children are the patients. Over the last few years, several thousand infants and children receiving intensive care have joined randomised controlled trials (RCT) in the UK, the majority of those conducted under the auspices of the National Institute for Health Research (NIHR) portfolio. Globally, tens of thousands of children and infants take part in RCTs. When those children survive, many continue to partake in studies with involvement over several years and potentially into adulthood. That is essential; in no other branch of medicine is it more important to meet the challenges of long-term follow-up and to consider the effects of trial interventions on a developing brain and metabolic control systems. However, sadly, not all these children survive and what then happens to their parents with regard to the original trial is largely unexplored in the published literature. The Bereavement and Randomised Controlled Trials (BRACELET) study explores these issues in both paediatric intensive care (PIC) and neonatal intensive care (NIC) settings. This is a mixed methods study including a quantitative survey of trials and centres, a qualitative study of practice and personal experience, and a methodological study with the aim of informing future research.1

The surveys showed that although around half of all paediatric intensive care units and neonatal intensive care units (NICUs) participated in at least one study during the 5 years studied (2002–2006), most participants were recruited from a smaller number of units. The majority of recruits (and deaths) were infants: in NIC trials, 17% babies died compared with 6% of children …

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