BACKGROUND: The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents. METHODS: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered. RESULTS: Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain. CONCLUSIONS: This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation. IMPACT: This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.

Clinic of Neonatology Department Mother Woman Child Lausanne University Hospital and University of Lausanne Lausanne Switzerland

Department of Neonatal Medicine School of Public Health Faculty of Medicine Imperial College London Chelsea and Westminster Campus London UK

Department of Neonatology CHI at Crumlin Dublin Ireland

Department of Neonatology Clinic for Paediatric Cardiology Intensive Care and Neonatology University Medical Centre Göttingen Göttingen Germany

Department of Neonatology Pirogov Russian National Research Medical University Moscow Russia

Department of Neonatology Radboud Institute for Health Sciences Radboud University Medical Center Amalia Children's Hospital Nijmegen The Netherlands

Department of Paediatrics Amsterdam UMC Emma Children's Hospital University of Amsterdam Amsterdam The Netherlands

Department of Paediatrics Coombe Women's and Infant's University Hospital Dublin Ireland

Department of Paediatrics Tergooi Hospital Blaricum The Netherlands

Department of Paediatrics University of Florida Gainesville FL USA

Department of Pathology Immunology and Laboratory Medicine University of Florida Gainesville FY USA

Department of Pediatrics and Adolescence Medicine University Hospital of North Norway Tromsø Norway

Department of Pediatrics Bern University Hospital University of Bern Bern Switzerland

Department of Pediatrics Division of Neonatology Erasmus MC Sophia Children's Hospital Rotterdam The Netherlands

Department of Pediatrics Women and Infants Hospital of Rhode Island Alpert Medical School of Brown University Providence RI USA

Discipline of Paediatrics Trinity College Dublin The University of Dublin and Children's Hospital Ireland at Tallaght Dublin Ireland

Division of Neonatal Perinatal Medicine Department of Pediatrics Columbia University Medical Center New York City NY USA

Division of Neonatology Edward Doisy Research Center Saint Louis University St Louis MO USA

Division of Woman and Baby Department of Neonatology Wilhelmina Children's Hospital and University of Utrecht Utrecht The Netherlands

Institute of Pathological Physiology 1st Faculty of Medicine Charles University Prague Czech Republic

Institute of Translational Medicine University of Liverpool Centre for Women's Health Research Liverpool Women's Hospital Liverpool UK

John Stearne Medical Library Trinity College Dublin St James' Hospital Dublin Ireland

Karolinska University Hospital and Karolinska Institutet Stockholm Sweden

Neonatal Directorate King Edward Memorial Hospital for Women Perth WA Australia

Neonatal Health and Development Telethon Kids Institute Perth WA Australia

Neonatal Unit Department of Obstetrics and Gynecology Motol University Hospital and 2nd Faculty of Medicine Prague Czech Republic

Paediatric Critical Care Research Group Child Health Research Centre University of Queensland Brisbane QLD Australia

Paediatric Intensive Care Unit Queensland Children's Hospital Brisbane QLD Australia

Paediatric Research Group Faculty of Health Sciences UiT The Arctic University of Norway Tromsø Norway

School of Nursing and Midwifery Faculty of Health University of Plymouth Plymouth UK

Trinity Research in Childhood Centre Trinity College Dublin Dublin Ireland

Trinity Translational Medicine Institute St James Hospital Dublin Ireland

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