Neonatal sepsis and mortality in low-income and middle-income countries from a facility-based birth cohort: an international multisite prospective observational study
Authors: Rebecca Milton, David Gillespie, Calie Dyer, Khadijeh Taiyari, Maria J Carvalho, Kathryn Thomson, Kirsty Sands, Edward A R Portal, Kerenza Hood, Ana Ferreira, Thomas Hender, Nigel Kirby, Jordan Mathias, Maria Nieto, William J Watkins, Delayehu Bekele, Mahlet Abayneh, Semaria Solomon, Sulagna Basu, Ranjan K Nandy, Bijan Saha, Kenneth Iregbu, Fatima Z Modibbo, Stella Uwaezuoke, Rabaab Zahra, Haider Shirazi, Syed U Najeeb, Jean-Baptiste Mazarati, Aniceth Rucogoza, Lucie Gaju, Shaheen Mehtar, Andre N H Bulabula, Andrew C Whitelaw, Timothy R Walsh, Grace J Chan, Oludare Odumade, Rozina Ambachew, Zenebe Gebre Yohannes, Gesit Metaferia, Redeat Workneh, Tefera Biteye, Yahya Zekaria Mohammed, Alula M Teklu, Balkachew Nigatu, Wendimagegn Gezahegn, Partha Sarathi Chakravorty, Sharmi Naha, Anuradha Mukherjee, Khairiyya Muhammad Umar, Asunugwo Vivian Akunna, Queen Nsude, Ifeoma Uke, Mary-Joe Okenu, Chinenye Akpulu, Chukwuemeka Mmadueke, Samuel Yakubu, Lamidi Audu, Nura Idris, Safiya Gambo, Jamila Ibrahim, Edwin Chinago, Ashiru Yusuf, Shamsudden Gwadabe, Adeola Adeleye, Muhammad Aliyu, Amina Muhammad, Aishatu Kassim, Aisha Sani Mukaddas, Rashida Yakubu Khalid, Fatima Ibrahim Alkali, Maryam Yahaya Muhammad, Fatima Muhammad Tukur, Surayya Mustapha Muhammad, Adeola Shittu, Murjanatu Bello, Fatima Habib Sa ad, Shaheed Zulfiqar, Adil Muhammad, Muhammad Hilal Jan, Lauren Paterson
Journal: The Lancet Global Health (2022)

BackgroundNeonatal 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.MethodsThe 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.FindingsBetween 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.InterpretationFindings 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.FundingBill & Melinda Gates Foundation.