Severe infection incidence among young infants in Dhaka, Bangladesh: an observational cohort study

IntroductionHeterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource s...

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Vydané v:	BMJ public health Ročník 3; číslo 2; s. e002383
Hlavní autori:	Fung, Alastair, Heasley, Cole, Pell, Lisa G, Bassani, Diego G, Shah, Prakesh S, Morris, Shaun K, Hamer, Davidson, Islam, Mohammad Shahidul, Mahmud, Abdullah Al, Pullenayegum, Eleanor, Saha, Samir K, Haque, Rashidul, Hossain, Md Iqbal, Chen, Chun-Yuan, Emdin, Abby, O’Callaghan, Karen M, Loutet, Miranda G, Sultana, Shamima, Billah, S M Masum, Gaffar, S M Abdul, Karim, Enamul, Sayed, Sharika, Yeasmin, Sultana, Hoque, Md Mahbubul, Ahmed, Tahmeed, Sarker, Shafiqul A, Roth, Daniel E
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	England BMJ Publishing Group Ltd 13.07.2025 BMJ Publishing Group LTD BMJ Publishing Group
Predmet:	Bacterial diseases Blood Caregivers Disease Transmission, Infectious Epidemiologic Research Design Heterogeneity Infants Infections Medical referrals Mortality Observational studies Original Research Prevalence Public Health Sepsis Bangladesh Dhaka Bangladesh Epidemiologic Research Design Public Health Prevalence Disease Transmission, Infectious
ISSN:	2753-4294, 2753-4294
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Abstract	IntroductionHeterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0–60 days using variations in case definitions.MethodsAmong 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death.ResultsSevere infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits.ConclusionsSevere infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary.
AbstractList	Introduction Heterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0–60 days using variations in case definitions.Methods Among 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death.Results Severe infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits.Conclusions Severe infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary. Heterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0-60 days using variations in case definitions.IntroductionHeterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0-60 days using variations in case definitions.Among 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death.MethodsAmong 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death.Severe infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits.ResultsSevere infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits.Severe infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary.ConclusionsSevere infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary. IntroductionHeterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0–60 days using variations in case definitions.MethodsAmong 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death.ResultsSevere infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits.ConclusionsSevere infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary. Heterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled trials (RCTs) of infection prevention interventions. To inform the design of infection prevention RCTs for infants in low-resource settings, we estimated the incidence of severe infection and death among Bangladeshi infants aged 0-60 days using variations in case definitions. Among 1939 infants born generally healthy in Dhaka, Bangladesh, severe infection was identified through up to 12 scheduled community health worker home visits from 0 to 60 days of age or through caregiver self-referral. The primary severe infection case definition combined physician documentation of standardised clinical signs and/or diagnosis of sepsis/SBI, plus either a positive blood culture or parenteral antibiotic treatment for ≥5 days. Incidence rates were estimated for the primary severe infection definition, the WHO definition of possible SBI, blood culture-confirmed infection and five alternative definitions including non-injury death. Severe infection incidence per 1000 infant-days was 1.2 (95% CI 0.97 to 1.4) using the primary definition, 0.84 (0.69 to 1.0) using the WHO definition of possible SBI, 0.026 (0.0085 to 0.081) using blood culture-confirmed infection and 0.061 (0.029 to 0.13) for death. One-third of cases met criteria for the primary severe infection definition through physician diagnosis of sepsis/SBI rather than the standardised clinical signs, and 85% of cases were identified following caregiver self-referral despite frequent scheduled visits. Severe infection incidence in infants varied considerably by case definition. Using a clinical sign-based definition may miss a substantial proportion of cases identified by physician diagnosis of sepsis/SBI. A consensus definition of severe infection in infants that balances permissiveness and stringency and can be operationalised in low-resource countries would improve the comparability of RCTs. If health facilities are accessible and caregivers readily seek care for infant illness, frequently scheduled home assessments may not be necessary.
Author	Fung, Alastair Sultana, Shamima Hossain, Md Iqbal Ahmed, Tahmeed Hoque, Md Mahbubul Morris, Shaun K Roth, Daniel E Hamer, Davidson Sarker, Shafiqul A Pullenayegum, Eleanor Saha, Samir K Mahmud, Abdullah Al Loutet, Miranda G Pell, Lisa G Shah, Prakesh S O’Callaghan, Karen M Billah, S M Masum Haque, Rashidul Karim, Enamul Gaffar, S M Abdul Chen, Chun-Yuan Emdin, Abby Yeasmin, Sultana Bassani, Diego G Islam, Mohammad Shahidul Sayed, Sharika Heasley, Cole
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Additional supplemental material is published online only. To view, please visit the journal online (https://doi.org/10.1136/bmjph-2024-002383). Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. AF received consulting fees from Brigham and Women’s Hospital for separate work on the diagnostic accuracy of clinical sign algorithms to identify sepsis in young infants. None of the other authors had competing interests to declare.
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References	Griffiths, Jenkins, Vargova (R15) 2019; 393 Strunk, Molloy, Mishra (R7) 2024; 404 Bakhuizen, de Haan, Teune (R3) 2014; 103 (R10) 2008; 371 Perin, Mulick, Yeung (R2) 2022; 6 Rudd, Johnson, Agesa (R5) 2020; 395 García, Allende-López, Morales-Ruíz (R19) 2022; 53 Khoury, Pillar, Shehadeh (R18) 2023; 182 Wynn, Wong, Shanley (R6) 2014; 15 Wynn (R8) 2016; 28 Schlapbach, Watson, Sorce (R16) 2024; 331 Hayes, Hartnett, Semova (R9) 2023; 93 Saha, Schrag, El Arifeen (R14) 2018; 392 Pell, Qamar, Bassani (R13) 2025; 10 Milton, Gillespie, Dyer (R4) 2022; 10 (R20) 2022; 12 2025112611401158000_3.2.e002383.11 2025112611401158000_3.2.e002383.10 2025112611401158000_3.2.e002383.21 Pell (2025112611401158000_3.2.e002383.13) 2025; 10 2025112611401158000_3.2.e002383.9 2025112611401158000_3.2.e002383.8 2025112611401158000_3.2.e002383.7 2025112611401158000_3.2.e002383.19 2025112611401158000_3.2.e002383.18 2025112611401158000_3.2.e002383.17 2025112611401158000_3.2.e002383.16 Milton (2025112611401158000_3.2.e002383.4) 2022; 10 2025112611401158000_3.2.e002383.14 2025112611401158000_3.2.e002383.12 (2025112611401158000_3.2.e002383.20) 2022; 12 2025112611401158000_3.2.e002383.6 2025112611401158000_3.2.e002383.5 2025112611401158000_3.2.e002383.3 2025112611401158000_3.2.e002383.2 Griffiths (2025112611401158000_3.2.e002383.15) 2019; 393 2025112611401158000_3.2.e002383.1
References_xml	– volume: 182 start-page: 3287 year: 2023 ident: R18 article-title: COVID-19 in neonates and infants younger than 6 months - a mild viral illness publication-title: Eur J Pediatr doi: 10.1007/s00431-023-05016-x – volume: 371 start-page: 135 year: 2008 ident: R10 article-title: Clinical signs that predict severe illness in children under age 2 months: a multicentre study publication-title: Lancet doi: 10.1016/S0140-6736(08)60106-3 – volume: 10 year: 2025 ident: R13 article-title: Neonatal administration of Lactiplantibacillus plantarum ATCC 202195 with or without fructooligosaccharide in Bangladesh: a placebo-controlled randomized trial publication-title: mSphere doi: 10.1128/msphere.01032-24 – volume: 15 start-page: 523 year: 2014 ident: R6 article-title: Time for a neonatal-specific consensus definition for sepsis publication-title: Pediatr Crit Care Med doi: 10.1097/PCC.0000000000000157 – volume: 331 start-page: 665 year: 2024 ident: R16 article-title: International Consensus Criteria for Pediatric Sepsis and Septic Shock publication-title: JAMA doi: 10.1001/jama.2024.0179 – volume: 395 start-page: 200 year: 2020 ident: R5 article-title: Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study publication-title: Lancet doi: 10.1016/S0140-6736(19)32989-7 – volume: 93 start-page: 1141 year: 2023 ident: R9 article-title: Neonatal sepsis definitions from randomised clinical trials publication-title: Pediatr Res doi: 10.1038/s41390-021-01749-3 – volume: 392 start-page: 145 year: 2018 ident: R14 article-title: Causes and incidence of community-acquired serious infections among young children in south Asia (ANISA): an observational cohort study publication-title: Lancet doi: 10.1016/S0140-6736(18)31127-9 – volume: 404 start-page: 277 year: 2024 ident: R7 article-title: Neonatal bacterial sepsis publication-title: Lancet doi: 10.1016/S0140-6736(24)00495-1 – volume: 12 year: 2022 ident: R20 article-title: Barriers to optimal care and strategies to promote safe and optimal management of sick young infants during the COVID-19 pandemic: A multi-country formative research study publication-title: J Glob Health doi: 10.7189/jogh.12.05023 – volume: 10 start-page: e661 year: 2022 ident: R4 article-title: Neonatal sepsis and mortality in low-income and middle-income countries from a facility-based birth cohort: an international multisite prospective observational study publication-title: Lancet Glob Health doi: 10.1016/S2214-109X(22)00043-2 – volume: 393 start-page: 423 year: 2019 ident: R15 article-title: Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(18)32221-9 – volume: 28 start-page: 135 year: 2016 ident: R8 article-title: Defining neonatal sepsis publication-title: Curr Opin Pediatr doi: 10.1097/MOP.0000000000000315 – volume: 6 start-page: 106 year: 2022 ident: R2 article-title: Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals publication-title: Lancet Child Adolesc Health doi: 10.1016/S2352-4642(21)00311-4 – volume: 103 start-page: 1211 year: 2014 ident: R3 article-title: Meta-analysis shows that infants who have suffered neonatal sepsis face an increased risk of mortality and severe complications publication-title: Acta Paediatr doi: 10.1111/apa.12764 – volume: 53 start-page: 252 year: 2022 ident: R19 article-title: COVID-19 in Neonates with Positive RT-PCR Test. 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Snippet	IntroductionHeterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised... Heterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised controlled... Introduction Heterogeneity in definitions of severe infection, sepsis and serious bacterial infection (SBI) in infants limits the comparability of randomised...
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SubjectTerms	Bacterial diseases Blood Caregivers Disease Transmission, Infectious Epidemiologic Research Design Heterogeneity Infants Infections Medical referrals Mortality Observational studies Original Research Prevalence Public Health Sepsis
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Title	Severe infection incidence among young infants in Dhaka, Bangladesh: an observational cohort study
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