Neonatal sepsis and mortality in low-income and middle-income countries from a facility-based birth cohort: an international multisite prospective observational study

BARNARDS Group

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Abstract

Background: Neonatal sepsis is a primary cause of neonatal mortality and is an urgent global health concern, especially within low-income and middle-income countries (LMICs), where 99% of global neonatal mortality occurs. The aims of this study were to determine the incidence and associations with neonatal sepsis and all-cause mortality in facility-born neonates in LMICs. Methods: The Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study recruited mothers and their neonates into a prospective observational cohort study across 12 clinical sites from Bangladesh, Ethiopia, India, Pakistan, Nigeria, Rwanda, and South Africa. Data for sepsis-associated factors in the four domains of health care, maternal, birth and neonatal, and living environment were collected for all mothers and neonates enrolled. Primary outcomes were clinically suspected sepsis, laboratory-confirmed sepsis, and all-cause mortality in neonates during the first 60 days of life. Incidence proportion of livebirths for clinically suspected sepsis and laboratory-confirmed sepsis and incidence rate per 1000 neonate-days for all-cause mortality were calculated. Modified Poisson regression was used to investigate factors associated with neonatal sepsis and parametric survival models for factors associated with all-cause mortality. Findings: Between Nov 12, 2015 and Feb 1, 2018, 29 483 mothers and 30 557 neonates were enrolled. The incidence of clinically suspected sepsis was 166·0 (95% CI 97·69–234·24) per 1000 livebirths, laboratory-confirmed sepsis was 46·9 (19·04–74·79) per 1000 livebirths, and all-cause mortality was 0·83 (0·37–2·00) per 1000 neonate-days. Maternal hypertension, previous maternal hospitalisation within 12 months, average or higher monthly household income, ward size (>11 beds), ward type (neonatal), living in a rural environment, preterm birth, perinatal asphyxia, and multiple births were associated with an increased risk of clinically suspected sepsis, laboratory-confirmed sepsis, and all-cause mortality. The majority (881 [72·5%] of 1215) of laboratory-confirmed sepsis cases occurred within the first 3 days of life. Interpretation: Findings from this study highlight the substantial proportion of neonates who develop neonatal sepsis, and the high mortality rates among neonates with sepsis in LMICs. More efficient and effective identification of neonatal sepsis is needed to target interventions to reduce its incidence and subsequent mortality in LMICs. Funding: Bill & Melinda Gates Foundation.

Original languageEnglish
Pages (from-to)e661-e672
JournalThe Lancet Global Health
Volume10
Issue number5
DOIs
Publication statusPublished - May 2022
Externally publishedYes

Bibliographical note

Funding Information:
We would first like to thank Padmini Srikantiah, Nicole Benson, Rasa Izadnegahdar, Keith Klugman, and Sara Vernam at the Bill & Melinda Gates Foundation. We would also like to thank the participants and their families, without whom we would not have been able to carry out BARNARDS. We would like to extend our thanks to two invaluable Placement Training Year students: Patrick Hogan and Habiba Saif. We thank and acknowledge the hard work of the team at Liofilchem, Roseto, Italy, specifically Fabio Brocco and Matteo Colletta. We thank Wendimagegn Gezahegn and Balkachew Nigatu at St Paul's Hospital Millennium Medical College for supporting the work in Ethiopia. We would like to acknowledge Rubina Kamran the microbiologist from Pakistan Institute of Medical Science who sadly passed away in 2018. The Centre for Trials Research is funded by Health and Care Research Wales and Cancer Research UK.

Funding Information:
We would first like to thank Padmini Srikantiah, Nicole Benson, Rasa Izadnegahdar, Keith Klugman, and Sara Vernam at the Bill & Melinda Gates Foundation. We would also like to thank the participants and their families, without whom we would not have been able to carry out BARNARDS. We would like to extend our thanks to two invaluable Placement Training Year students: Patrick Hogan and Habiba Saif. We thank and acknowledge the hard work of the team at Liofilchem, Roseto, Italy, specifically Fabio Brocco and Matteo Colletta. We thank Wendimagegn Gezahegn and Balkachew Nigatu at St Paul's Hospital Millennium Medical College for supporting the work in Ethiopia. We would like to acknowledge Rubina Kamran the microbiologist from Pakistan Institute of Medical Science who sadly passed away in 2018. The Centre for Trials Research is funded by Health and Care Research Wales and Cancer Research UK.

Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

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