Evidence map›Paper›PMID 34997225›Full record

SynthesisPediatric research2022

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

Cían J Henry, Gergana Semova, Ellen Barnes, Isabel Cotter, Tara Devers, Aisyah Rafaee, Andreea Slavescu, Niamh O Cathain, Danielle McCollum, Edna Roche and 25 more

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Pediatric research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. DecipheringMicroorganisms · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 11 countries.

Cían J HenryDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Gergana SemovaDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Ellen BarnesDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Isabel CotterDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Tara DeversDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Aisyah RafaeeDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Andreea SlavescuDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Niamh O CathainDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Danielle McCollumDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Edna RocheDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
David MocklerJohn Stearne Medical Library, Trinity College Dublin, St. James' Hospital, Dublin, Ireland.
John AllenDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Judith MeehanDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Claus KlingenbergDepartment of Pediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway.
Jos M LatourSchool of Nursing and Midwifery, Faculty of Health, University of Plymouth, Plymouth, UK.
Agnes van den HoogenDivision of Woman and Baby, Department of Neonatology, Wilhelmina Children's Hospital (part of UMC Utrecht) and University of Utrecht, Utrecht, The Netherlands.
Tobias StrunkNeonatal Health and Development, Telethon Kids Institute, Perth, WA, Australia.
Eric GiannoniClinic of Neonatology, Department Mother-Woman-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Luregn J SchlapbachPaediatric Critical Care Research Group, Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia.
Marina DegtyarevaDepartment of Neonatology, Pirogov Russian National Research Medical University, Moscow, Russia.
Frans B PlötzDepartment of Paediatrics, Tergooi Hospital, Blaricum, The Netherlands.
Willem P de BoodeDepartment of Neonatology, Radboud Institute for Health Sciences, Radboud University Medical Center, Amalia Children's Hospital, Nijmegen, The Netherlands.
Lars NaverKarolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
James L WynnDepartment of Paediatrics, University of Florida, Gainesville, FL, USA.
Helmut KüsterDepartment of Neonatology, Clinic for Paediatric Cardiology, Intensive Care and Neonatology, University Medical Centre Göttingen, Göttingen, Germany.
Jan JanotaNeonatal Unit, Department of Obstetrics and Gynecology, Motol University Hospital and Second Faculty of Medicine, Prague, Czech Republic.
Fleur M KeijDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Irwin K M ReissDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Joseph M BlissDepartment of Pediatrics, Women & Infants Hospital of Rhode Island, Alpert Medical School of Brown University, Providence, RI, USA.
Richard PolinDivision of Neonatal-Perinatal Medicine, Department of Pediatrics, Columbia University Medical Center, New York City, NY, USA.
Joyce M KoenigDivision of Neonatology, Edward Doisy Research Center, Saint Louis University, St. Louis, MO, USA.
Mark A TurnerInstitute of Translational Medicine, University of Liverpool, Centre for Women's Health Research, Liverpool Women's Hospital, Liverpool, UK.
Christopher GaleDepartment of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Campus, London, UK.
Eleanor J MolloyDiscipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland. Eleanor.molloy@tcd.ie.
Infection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)
Trinity College Dublin · IEErasmus MC - Sophia Children’s Hospital · NLSt. James's Hospital · IEColumbia University Irving Medical Center · USImperial College London · GBKarolinska Institutet · SEPirogov Russian National Research Medical University · RUQueensland Children’s Hospital · AURadboud University Medical Center · NLSaint Louis University · USTergooi · NLThe Kids Research Institute Australia · AUUiT The Arctic University of Norway · NOUniversitätsmedizin Göttingen · DEUniversity Hospital in Motol · CZUniversity of Florida · USUniversity of Lausanne · CHUniversity of Liverpool · GBUniversity of Plymouth · GBWilhelmina Children's Hospital · NL

Funding

Medical Research Council MR/N008405/1
6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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.

resultsAmong 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.

conclusionsThis 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.

Indexed as

Neonatal SepsisResearch DesignDelphi TechniqueHumansInfant, NewbornOutcome Assessment, Health CareRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID34997225
PMCPMC9064797
OpenAlexW4206140182

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.