Neonatal sepsis and mortality in low-income and middle-income countries from a facility-based birth cohort: an international multisite prospective observational study.
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Milton Rebecca, Gillespie David, Dyer Calie, Taiyari Khadijeh, Carvalho Maria J, Thomson Kathryn, Sands Kirsty, Portal Edward A R, Hood Kerenza, Ferreira Ana, Hender Thomas, Kirby Nigel, Mathias Jordan, Nieto Maria, Watkins William J, Bekele Delayehu, Abayneh Mahlet, Solomon Semaria, Basu Sulagna, Nandy Ranjan K, Saha Bijan, Iregbu Kenneth, Modibbo Fatima Z, Uwaezuoke Stella, Zahra Rabaab, Shirazi Haider, Najeeb Syed U, Mazarati Jean-Baptiste, Rucogoza Aniceth, Gaju Lucie, Mehtar Shaheen, Bulabula Andre N H, Whitelaw Andrew C, Walsh Timothy R, BARNARDS Group, Chan Grace J
Аннотация
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.