Mussa Fatima M, Joachim Agricola, Moshiro Robert, Masoud Salim S, Addo Marylyn M, Pagel Julia, Krumkamp Ralf, Kobbe Robin, Salim Nahya
Department of Pediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Department of Microbiology and Immunology, School of Diagnostic Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
PLoS One. 2025 Jun 2;20(6):e0325099. doi: 10.1371/journal.pone.0325099. eCollection 2025.
Neonatal mortality remains high in many low- and middle-income countries (LMICs), with neonatal sepsis and antimicrobial resistance (AMR) posing significant threats to newborns, particularly in sub-Saharan Africa (SSA). Tanzania is among the countries with the highest neonatal mortality rates, with sepsis being a major contributor. Gut dysbiosis has been identified as a risk factor for neonatal sepsis in high-income countries, due to factors like abundance of pathogenic bacteria, decrease in microbiome diversity, intestinal barrier defects and bacterial translocation. Understanding gut dysbiosis in the local setting and its role in sepsis development may offer new prevention strategies, such as probiotics for high-risk preterm infants.
This prospective neonatal cohort, established at Muhimbili National Hospital (MNH) in Dar es Salaam, Tanzania, aims to analyze the gut microbiome of preterm infants and explore associations with neonatal late-onset sepsis (LOS). Additionally, data on bacterial pathogens of bloodstream infections and AMR prevalence will be identified. Secondary endpoints include clinical LOS, sepsis-related death, death from any cause, and hospital discharge outcomes.
Eligible preterm neonates (28 + 0 to <34 weeks of gestational age, birth weight ≥ 1000g) will be recruited with maternal consent. Socio-demographic and clinical data, microbiological details of blood pathogens, and a set of fresh frozen fecal samples during the 28 days observation period will be collected. The study targets a sample size of 1350 participants and we expect 72-135 culture-proven LOS during a study period of 18 months. Fecal samples will undergo next-generation sequencing (NGS) to analyze microbial community functions in comparison to matched controls.
This collaborative study between universities in Tanzania and Germany, aims to analyze the neonatal microbiome in relation to sepsis development and AMR of blood culture isolates to enhance neonatal sepsis care, improve diagnostics and treatment. The project will offer insights into potential therapeutic strategies for the future, promote academic exchange, capacity building and research on African microbiomes.
在许多低收入和中等收入国家（LMICs），新生儿死亡率仍然很高，新生儿败血症和抗菌药物耐药性（AMR）对新生儿构成重大威胁，特别是在撒哈拉以南非洲（SSA）。坦桑尼亚是新生儿死亡率最高的国家之一，败血症是主要原因。在高收入国家，肠道菌群失调已被确定为新生儿败血症的一个风险因素，原因包括病原菌数量增加、微生物群多样性降低、肠道屏障缺陷和细菌易位。了解当地环境中的肠道菌群失调及其在败血症发展中的作用可能会提供新的预防策略，例如为高危早产儿使用益生菌。
这项前瞻性新生儿队列研究在坦桑尼亚达累斯萨拉姆的穆希姆比利国家医院（MNH）开展，旨在分析早产儿的肠道微生物群，并探索与新生儿晚发性败血症（LOS）的关联。此外，还将确定血流感染的细菌病原体数据和AMR患病率。次要终点包括临床LOS、败血症相关死亡、任何原因导致的死亡以及出院结局。
符合条件的早产儿（胎龄28 + 0至<34周，出生体重≥1000g）将在获得母亲同意后入组。将收集社会人口统计学和临床数据、血液病原体的微生物学细节，以及观察期28天内的一组新鲜冷冻粪便样本。该研究的目标样本量为135名参与者，预计在18个月的研究期间有72 - 135例经培养证实的LOS。粪便样本将进行下一代测序（NGS），以与匹配的对照相比分析微生物群落功能。
坦桑尼亚和德国的大学之间的这项合作研究旨在分析与败血症发展和血培养分离株的AMR相关的新生儿微生物群，以加强新生儿败血症护理，改善诊断和治疗。该项目将为未来潜在的治疗策略提供见解，促进学术交流、能力建设以及非洲微生物群的研究。
