Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials

Autor: Henry, CJ, Semova, G, Barnes, E, Cotter, I, Devers, T, Rafaee, A, Slavescu, A, Cathain, NO, McCollum, D, Roche, E, Mockler, D, Allen, J, Meehan, J, Klingenberg, C, Latour, JM, Van den Hoogen, A, Strunk, T, Giannoni, E, Schlapbach, LJ, Degtyareva, M, Plötz, FB, De Boode, WP, Naver, L, Wynn, JL, Küster, H, Janota, J, Keij, FM, Reiss, IKM, Bliss, JM, Polin, R, Koenig, JM, Turner, MA, Gale, C, Molloy, EJ, Infection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)
Přispěvatelé: Infection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)
Jazyk: angličtina
Rok vydání: 2022
Předmět:
DAYS ANTIBIOTIC-THERAPY
BIRTH-WEIGHT INFANTS
Delphi Technique
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
IMMUNE GLOBULIN THERAPY
PLACEBO-CONTROLLED TRIAL
Pediatrics
1117 Public Health and Health Services
Outcome Assessment
Health Care
Humans
Randomized Controlled Trials as Topic
EARLY-ONSET SEPSIS
Science & Technology
Infection
Inflammation
Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)
Infant
Newborn
COLONY-STIMULATING FACTOR
Treatment Outcome
Research Design
Pediatrics
Perinatology and Child Health
ENRICHED INTRAVENOUS IMMUNOGLOBULIN
ORAL ZINC SUPPLEMENTATION
1114 Paediatrics and Reproductive Medicine
Neonatal Sepsis/diagnosis
Neonatal Sepsis/therapy
Neonatal Sepsis
Life Sciences & Biomedicine
BUFFY COAT TRANSFUSIONS
GUIDED DECISION-MAKING
Zdroj: Pediatric research, vol. 91, no. 4, pp. 735-742
Pediatric Research, 91, 4, pp. 735-742
Pediatric Research, 91, 735-742
ISSN: 0031-3998
Popis: 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.
Databáze: OpenAIRE
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