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The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials

Claire Snowdon1, Sheila E Harvey, Peter Brocklehurst

  • 1Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, UK.

Trials
|May 28, 2010
PubMed

Insights

Deaths in pediatric and neonatal intensive care trials are common, yet few trials have bereavement support policies. This study highlights the need for developing and assessing bereavement care strategies in clinical trials.

Area of Science:

  • Pediatric Intensive Care
  • Neonatal Intensive Care
  • Clinical Trials
  • Bereavement Studies

Background:

  • Research on death and bereavement in pediatric and neonatal intensive care randomized controlled trials (RCTs) is limited.
  • The Bereavement and RAndomised ControlLEd Trials (BRACELET) Study aimed to assess trial activity, mortality, and bereavement support policies in UK NICUs and PICUs between 2002-2006.
  • Understanding these factors is crucial for developing future policies and practices for bereavement support following a child's trial enrollment.

Purpose of the Study:

  • To determine the extent of trial activity in UK neonatal and paediatric intensive care units from 2002 to 2006.
  • To quantify the number of deaths occurring before hospital discharge among participants in these trials.
  • To examine variations in mortality rates across different intensive care units and trials, and to assess the availability of bereavement support policies within trials.

Main Methods:

  • A survey of neonatal units (level 2 or 3 care) and paediatric units (level II care or above) in the UK.
  • A survey of randomized controlled trials involving intensive care patients or parents, with interventions designed to affect patient outcomes.
  • Data collection on trial participation, patient enrollment, mortality, and existing bereavement support policies.

Main Results:

  • Information was gathered from 191 neonatal and 28 paediatric units, with 90 units participating in at least one trial.
  • Fifty trials were identified, enrolling 3,137 infants in neonatal trials and 210 children in paediatric trials.
  • A total of 534 participants (16%) died post-enrollment (522 in neonatal, 12 in paediatric trials); only three trials reported a formal bereavement policy.

Conclusions:

  • A significant number of deaths occurred among participants enrolled in neonatal and paediatric intensive care trials.
  • Bereavement support policies were largely absent within the studied trials.
  • Units and trials with higher mortality rates may be best positioned to lead the development and evaluation of bereavement support strategies.
Abstract

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