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The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials.
Trials. 2010 May 26; 11:65.T

Abstract

BACKGROUND

The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ControlLEd Trials (BRACELET) Study were to determine trial activity in UK neonatal and paediatric intensive care (2002-06); numbers of deaths before hospital discharge; and variation in mortality across intensive care units and trials and to determine whether bereavement support policies were available within trials. These are essential prerequisites to considering the implications of future policies and practice subsequent to bereavement following a child's enrollment in a trial.

METHODS

The units survey involved neonatal units providing level 2 or 3 care, and paediatric units providing level II care or above; the trials survey involved trials where allocation was randomized and interventions were delivered to intensive care patients, or to parents but designed to affect patient outcomes.

RESULTS

Information was available from 191/220 (87%) neonatal units (149 level 2 or 3 care); and 28/32 (88%) paediatric units. 90/177 (51%) eligible responding units participated in one or more trial (76 neonatal, 14 paediatric) and 54 neonatal units and 6 paediatric units witnessed at least one death. 50 trials were identified (36 neonatal, 14 paediatric). 3,137 babies were enrolled in neonatal trials, 210 children in paediatric trials. Deaths ranged 0-278 (median [IQR interquartile range] 2 [1, 14.5]) per neonatal trial, 0-4 (median [IQR] 1 [0, 2.5]) per paediatric trial. 534 (16%) participants died post-enrollment: 522 (17%) in neonatal trials, 12 (6%) in paediatric trials. Trial participants ranged 1-236 (median [IQR] 21.5 [8, 39.8]) per neonatal unit, 1-53 (median [IQR] 11.5 [2.3, 33.8]) per paediatric unit. Deaths ranged 0-37 (median [IQR] 3.5 [0.3, 8.8]) per neonatal unit, 0-7 (median [IQR] 0.5 [0, 1.8]) per paediatric unit. Three trials had a formal policy for responding to bereavement.

CONCLUSIONS

A substantial number of deaths after trial enrollment were identified, distributed over many trials and units. Few trial teams had responses to bereavement in place. Those with the largest numbers of deaths might be best placed to collaborate in developing and assessing responses to bereavement.

Authors+Show Affiliations

Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20504341

Citation

Snowdon, Claire, et al. "The BRACELET Study: Surveys of Mortality in UK Neonatal and Paediatric Intensive Care Trials." Trials, vol. 11, 2010, p. 65.
Snowdon C, Harvey SE, Brocklehurst P, et al. The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials. Trials. 2010;11:65.
Snowdon, C., Harvey, S. E., Brocklehurst, P., Tasker, R. C., Platt, M. P., Allen, E., & Elbourne, D. (2010). The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials. Trials, 11, 65. https://doi.org/10.1186/1745-6215-11-65
Snowdon C, et al. The BRACELET Study: Surveys of Mortality in UK Neonatal and Paediatric Intensive Care Trials. Trials. 2010 May 26;11:65. PubMed PMID: 20504341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials. AU - Snowdon,Claire, AU - Harvey,Sheila E, AU - Brocklehurst,Peter, AU - Tasker,Robert C, AU - Platt,Martin P Ward, AU - Allen,Elizabeth, AU - Elbourne,Diana, Y1 - 2010/05/26/ PY - 2009/12/17/received PY - 2010/05/26/accepted PY - 2010/5/28/entrez PY - 2010/5/28/pubmed PY - 2010/9/30/medline SP - 65 EP - 65 JF - Trials JO - Trials VL - 11 N2 - BACKGROUND: The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ControlLEd Trials (BRACELET) Study were to determine trial activity in UK neonatal and paediatric intensive care (2002-06); numbers of deaths before hospital discharge; and variation in mortality across intensive care units and trials and to determine whether bereavement support policies were available within trials. These are essential prerequisites to considering the implications of future policies and practice subsequent to bereavement following a child's enrollment in a trial. METHODS: The units survey involved neonatal units providing level 2 or 3 care, and paediatric units providing level II care or above; the trials survey involved trials where allocation was randomized and interventions were delivered to intensive care patients, or to parents but designed to affect patient outcomes. RESULTS: Information was available from 191/220 (87%) neonatal units (149 level 2 or 3 care); and 28/32 (88%) paediatric units. 90/177 (51%) eligible responding units participated in one or more trial (76 neonatal, 14 paediatric) and 54 neonatal units and 6 paediatric units witnessed at least one death. 50 trials were identified (36 neonatal, 14 paediatric). 3,137 babies were enrolled in neonatal trials, 210 children in paediatric trials. Deaths ranged 0-278 (median [IQR interquartile range] 2 [1, 14.5]) per neonatal trial, 0-4 (median [IQR] 1 [0, 2.5]) per paediatric trial. 534 (16%) participants died post-enrollment: 522 (17%) in neonatal trials, 12 (6%) in paediatric trials. Trial participants ranged 1-236 (median [IQR] 21.5 [8, 39.8]) per neonatal unit, 1-53 (median [IQR] 11.5 [2.3, 33.8]) per paediatric unit. Deaths ranged 0-37 (median [IQR] 3.5 [0.3, 8.8]) per neonatal unit, 0-7 (median [IQR] 0.5 [0, 1.8]) per paediatric unit. Three trials had a formal policy for responding to bereavement. CONCLUSIONS: A substantial number of deaths after trial enrollment were identified, distributed over many trials and units. Few trial teams had responses to bereavement in place. Those with the largest numbers of deaths might be best placed to collaborate in developing and assessing responses to bereavement. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/20504341/The_BRACELET_Study:_surveys_of_mortality_in_UK_neonatal_and_paediatric_intensive_care_trials_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-65 DB - PRIME DP - Unbound Medicine ER -