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Hypothermia for perinatal asphyxia: trial-based quality of life at 6–7 years
  1. Helen Campbell1,
  2. Oya Eddama1,
  3. Denis Azzopardi2,3,
  4. A David Edwards2,
  5. Brenda Strohm1,
  6. Oliver Rivero-Arias1
  1. 1 National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK
  2. 2 Centre for the Developing Brain, King’s College, London, UK
  3. 3 Institute of Clinical Sciences, Imperial College, London, UK
  1. Correspondence to Dr Oliver Rivero-Arias, National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK; oliver.rivero{at}npeu.ox.ac.uk

Abstract

Objective To assess the impact of hypothermic neural rescue at birth on health-related quality of life (HRQL) in middle childhood.

Design Six-year to 7-year follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) Trial.

Setting Community study including a single parental questionnaire to collect information on children’s HRQL.

Patients 145 children (70 in the control group, 75 in the hypothermia group) whose parents consented and returned the questionnaire.

Interventions Intensive care with cooling of the body to 33.5°C for 72 hours or intensive care alone.

Main outcome measures HRQL attributes and utility scores using the Health Utilities Index (HUI).

Results At 6–7 years, speech appeared disproportionately affected when compared with other aspects of HRQL but levels of normal emotional functioning were similar in both groups. The mean (SE) HUI3 HRQL scores were 0.73 (0.05) in the hypothermia group and 0.62 (0.06) in the control group; mean difference (95% CI) 0.11 (−0.04 to 0.26).

Conclusions Findings of non-significant differences were not unexpected; the study used data from long-term survivors in a neonatal trial and was underpowered. However, results favoured moderate hypothermia and so complement the clinical results of the TOBY Children study. The work provides further insight into the long-term HRQL impact of perinatal asphyxial encephalopathy and provides previously unavailable utility data with which to contemplate the longer term cost-effectiveness of hypothermic neural rescue.

Trial registration number This study reports on the follow-up of the TOBY clinical trial: ClinicalTrials.gov number NCT01092637.

  • perinatal asphyxial encephalopathy
  • moderate hypothermia
  • health-related quality of life
  • long-term
  • health utilities index

This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • HC and OR-A contributed equally.

  • Contributors HC conducted aspects of the statistical analyses, wrote the manuscript with OR-A and revised and approved the final version for submission. OE conducted aspects of the statistical analysis and revised and approved the final manuscript for submission. DA was the chief investigator of the TOBY Children Study, secured funding for the study, contributed to the design of the statistical analysis plan and revised and approved the final manuscript for submission. ADE was a principal investigator of the TOBY Children Study, secured funding for the study, contributed to the design of the statistical analysis plan and revised and approved the final manuscript for submission. BS was the study coordinator of the TOBY Children Study, monitored and supervised the data collection, clarified data-related issues and revised and approved the final manuscript for submission. OR-A designed the statistical analysis plan of the study, supervised the statistical analysis, conducted the multiple imputation method for the missing data, wrote the manuscript jointly with HC and revised and approved the final version for submission.

  • Funding This study was supported by the UK Medical Research Council and the National Institute for Health Research Biomedical Research Centres at Imperial College London, the University of Oxford and King’s College London.

  • Disclaimer The study sponsor had no role in the study design; collection, analysis and interpretation of data; writing the report; or in the decision to submit the article for publication.

  • Competing interests None declared.

  • Patient consent Parental/guardian consent obtained.

  • Ethics approval The National Research Ethics Service in the UK and the relevant ethics review board at each of the institutions outside the UK approved the TOBY protocol.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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