Consensus definition and diagnostic criteria for neonatal encephalopathy-study protocol for a real-time modified delphi study

Aoife Branagan, Discipline of Paediatrics, Trinity College Dublin, the University of Dublin, Dublin, Ireland.
Tim Hurley, Discipline of Paediatrics, Trinity College Dublin, the University of Dublin, Dublin, Ireland.
Fiona Quirke, Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Dublin, Ireland.
Declan Devane, Health Research Board-Trials Methodology, Research Network (HRB-TMRN), University of Galway, Galway, Ireland.
Petek E. Taneri, Health Research Board-Trials Methodology, Research Network (HRB-TMRN), University of Galway, Galway, Ireland.
Nadia Badawi, Cerebral Palsy Alliance Research Institute, Specialty of Child & Adolescent Health, Sydney Medical School, Faculty of Medicine & Health, The University of Sydney, Sydney, NSW, Australia.
Bharati Sinha, Department of Pediatrics, Boston Medical Center, Boston, MA, USA.
Cynthia Bearer, Division of Neonatology, Department of Pediatrics, Rainbow Babies & Children's Hospital, Cleveland, OH, USA.
Frank H. Bloomfield, Liggins Institute, University of Auckland, Auckland, New Zealand.
Sonia L. Bonifacio, Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.
Geraldine Boylan, INFANT Research Centre, Cork, Ireland.
Suzann K. Campbell, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.
Lina Chalak, Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Mary D'Alton, Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.
Linda S. deVries, Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.
Mohamed El Dib, Division of Newborn Medicine, Department of Pediatrics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Donna M. Ferriero, Departments of Neurology and Pediatrics, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
Chris Gale, Neonatal Medicine, School of Public Health, Faculty of Medicine, Chelsea and Westminster Campus, Imperial College London, London, UK.
Pierre Gressens, Université Paris Cité, Inserm, NeuroDiderot, 75019, Paris, France.
Alistair J. Gunn, Departments of Physiology and Paediatrics, School of Medical Sciences, University of Auckland, Auckland, New Zealand.
Sarah Kay, PEEPS-HIE, Manchester, UK.
Beccy Maeso, James Lind Alliance, School of Healthcare Enterprise and Innovation, University of Southampton, Southampton, UK.
Sarah B. Mulkey, Children's National Hospital, Washington, DC, USA.
Deirdre M. Murray, INFANT Research Centre, Cork, Ireland.
Karin B. Nelson, National Institutes of Health, National Institute of Neurological Diseases and Stroke, Bethesda, MD, USA.
Tetyana H. Nesterenko, Department of Neonatology, Cleveland Clinic Children's Hospital, Cleveland, OH, USA.
Betsy Pilon, Hope for HIE, West Bloomfield, MI, USA.
Nicola J. Robertson, Institute for Women's Health, University College London, London, UK.
Karen Walker, Department of Newborn Care, Royal Prince Alfred Hospital, Sydney, Local Health District, Sydney, Australia.
Courtney J. Wusthoff, Division of Child Neurology, Stanford University, Palo Alto, CA, USA.
Eleanor J. Molloy, Discipline of Paediatrics, Trinity College Dublin, the University of Dublin, Dublin, Ireland. Eleanor.molloy@tcd.ie.

Document Type

Journal Article

Publication Date

6-20-2024

Journal

Pediatric research

DOI

10.1038/s41390-024-03303-3

Abstract

BACKGROUND: 'Neonatal encephalopathy' (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic criteria creates difficulty in the design and interpretation of research and complicates communication with families. The DEFINE study aims to use a modified Delphi approach to form a consensus definition for NE, and diagnostic criteria. METHODS: Directed by an international steering group, we will conduct a systematic review of the literature to assess the terminology used in trials of NE, and with their guidance perform an online Real-time Delphi survey to develop a consensus diagnosis and criteria for NE. A consensus meeting will be held to agree on the final terminology and criteria, and the outcome disseminated widely. DISCUSSION: A clear and consistent consensus-based definition of NE and criteria for its diagnosis, achieved by use of a modified Delphi technique, will enable more comparability of research results and improved communication among professionals and with families. IMPACT: The terms Neonatal Encephalopathy and Hypoxic Ischaemic Encephalopathy tend to be used interchangeably in the literature to describe a term newborn with signs of encephalopathy at birth. This creates difficulty in communication with families and carers, and between medical professionals and researchers, as well as creating difficulty with performance of research. The DEFINE project will use a Real-time Delphi approach to create a consensus definition for the term 'Neonatal Encephalopathy'. A definition formed by this consensus approach will be accepted and utilised by the neonatal community to improve research, outcomes, and parental experience.

Department

Neurology

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