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Record W4283581867 · doi:10.1101/2022.06.21.22276677

The NeoSep Severity and Recovery scores to predict mortality in hospitalized neonates and young infants with sepsis derived from the global NeoOBS observational cohort study

2022· preprint· en· W4283581867 on OpenAlexaff
Neal Russell, Wolfgang Stöhr, Aislinn Cook, James A. Berkley, B. Adhisivam, Ramesh Agarwal, ASM Nawshad Uddin Ahmed, Manica Balasegaram, Neema Chami, Adrie Bekker, Davide Bilardi, Cristina Gardonyi Carvalheiro, Suman Chaurasia, Viviane Rinaldi Favarin Colas, Simon Cousens, Ana Carolina Dantas de Assis, Dong Han, Angela Dramowski, Jinxing Feng, Y. Glupczynski, Srishti Goel, Herman Goossens, Doan Thi Huong Hao, Mahmudul Hasan, Tatiana Munera Huertas, Nathalie Khavessian, Angeliki Kontou, Tomislav Kostyanev, Premsak Laoyookhon, Sorasak Lochindarat, Maia De Luca, Surbhi Malhotra‐Kumar, Nivedita Mondal, Nitu Mundhra, Philippa Musoke, Marisa Márcia Mussi‐Pinhata, Ruchi Nanavati, Firdose Nakwa, Sushma Nangia, Alessandra Nardone, Borna Nyaoke, Christina W. Obiero, Ping Wang, Kanchana Preedisripipat, Shamim Qazi, Lifeng Qi, Amy Riddell, Lorenza Romani, Praewpan Roysuwan, Robin Saggers, Samir K. Saha, Kosmas Sarafidis, Valerie Tusibira, Sithembiso Velaphi, Tuba Vilken, Xiaojiao Wang, Yajuan Wang, Yonghong Yang, Sally Ellis, Julia Bielicki, A. Sarah Walker, Paul T. Heath, Mike Sharland

Bibliographic record

VenuemedRxiv · 2022
Typepreprint
Languageen
FieldMedicine
TopicNeonatal and Maternal Infections
Canadian institutionsInstitute of Infection and Immunity
Fundersnot available
KeywordsMedicineSepsisObservational studyPediatricsCohort studyCohortClinical trialProspective cohort studyInternal medicine

Abstract

fetched live from OpenAlex

Abstract Background Sepsis severity scores are used in clinical practice and trials to define risk groups. There are limited data to derive hospital-based sepsis severity scores for neonates and young infants in high-burden low- and middle-income country (LMIC) settings where trials are urgently required. We aimed to create linked sepsis severity and recovery scores applicable to hospitalized neonates and young infants in LMIC which could be used to inform antibiotic trials. Methods & Findings A prospective observational cohort study was conducted across 19 hospitals in 11 countries in sub-Saharan Africa, Asia, Latin America and Europe. Infants aged <60 days with clinical sepsis fulfilling at least two clinical or laboratory criteria (≥1 clinical) were enrolled. Primary outcome was 28-day mortality. Two prediction models were developed for 1) 28-day mortality from factors at sepsis presentation (baseline NeoSep Severity Score), and 2) daily risk of death on IV antibiotics from daily updated assessments (NeoSep Recovery Score). Multivariable Cox regression models included a randomly selected 85% of infants, with 15% for validation. 3204 infants were enrolled between 2018-2020. Median age was 5 days (IQR 2-15), 90.4% (n=2,895) were <28 days. Median birth weight was 2500g (1400-3000g), and a median of 4 clinical (IQR 2-5) and 1 laboratory (0-2) signs were present. Overall mortality was 11.3% (95%CI 10.2-12.5%; n=350). A baseline NeoSep Severity Score from infants characteristics, respiratory support, and clinical signs (no laboratory tests) at presentation had a C-index 0.77 (95%CI: 0.75-0.80) and 0.76 (0.69-0.82) in derivation and validation samples, respectively. Mortality in the validation sample was 1.6% (3/189; 95%CI: 0.5-4.6%), 11.0% (27/245; 7.7-15.6%), and 27.3% (12/44; 16.3-41.8%) in low (score 0-4), medium (5-8) and high (9-16) risk groups, respectively, with similar performance across subgroups. A related NeoSep Recovery Score based on evolving post-baseline clinical signs and supportive care discriminated well between infants who died or survived the following day or subsequent few days. The area under the ROC curve for score on day 2 and death in the following 5 days was 0.82 (95%CI 0.78-0.85) and 0.85 (95%CI 0.78-0.93) in the derivation and validation data, respectively. Conclusion The baseline NeoSep Severity Score predicted 28-day mortality and could identify infants with high risk of mortality for inclusion in hospital-based sepsis trials. The NeoSep Recovery Score predicts day-by-day inpatient mortality and could, with further validation, help to identify poor response to antibiotics. Author Summary Why was this study done? ➣ Evidence to guide hospital-based antibiotic treatment of sepsis in neonates and young infants is scarce, and clinical trials are particularly urgent in low- and middle-income (LMIC) settings where antimicrobial resistance threatens to undermine existing guidelines ➣ There is limited data to inform the design of antibiotic trials in LMIC settings, particularly to define risk stratification and inclusion and escalation criteria in hospitalised neonates and young infants What did the researchers do and find? ➣ To our knowledge this is the first global, prospective, hospital-based observational study of clinically diagnosed neonatal sepsis across 4 continents including LMIC settings, with extensive daily data collection on clinical status, antibiotic use and outcomes. ➣ There was a high mortality among infants with sepsis in LMIC hospital settings. 4 non-modifiable and 6 modifiable factors predicted mortality and were included in a NeoSep Severity score which defines patterns of mortality risk at baseline ➣ A NeoSep Recovery Score including the same modifiable factors (with the addition of cyanosis) predicted mortality on the following day during the course of treatment. What do these findings mean? ➣ The NeoSep Severity Score and NeoSep Recovery score are now informing inclusion and escalation criteria in the NeoSep1 antibiotic trial ( ISRCTN48721236 ) which aims to identify novel first- and second-line empiric antibiotic regimens for neonatal sepsis ➣ The NeoSep Severity Score could be used to predict mortality at baseline in future studies of targeting resources in routine care. With further validation, the NeoSep Recovery Score could potentially be used to identify poor response to empiric antibiotic treatment

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.017
Threshold uncertainty score0.972

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.001
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.026
GPT teacher head0.295
Teacher spread0.269 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations4
Published2022
Admission routes1
Has abstractyes

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