Institut de Recherche pour le Développement (IRD), Mère et enfant face aux infections tropicales (UMR216), Paris, France.
COMUE Sorbonne Paris Cité, Universite Paris Descartes, Paris, Île-de-France, France.
BMJ Open. 2020 Jul 23;10(7):e036905. doi: 10.1136/bmjopen-2020-036905.
Neonatal sepsis outreaches all causes of neonatal mortality worldwide and remains a major societal burden in low and middle income countries. In addition to limited resources, endemic morbidities, such as malaria and prematurity, predispose neonates and infants to invasive infection by altering neonatal immune response to pathogens. Nevertheless, thoughtful epidemiological, diagnostic and immunological evaluation of neonatal sepsis and the impact of gestational malaria have never been performed.
A prospective longitudinal multicentre follow-up of 580 infants from birth to 3 months of age in urban and suburban Benin will be performed. At delivery, and every other week, all children will be examined and clinically evaluated for occurrence of sepsis. At delivery, cord blood systematic analysis of selected plasma and transcriptomic biomarkers (procalcitonin, interleukin (IL)-6, IL-10, IP10, and ) associated with sepsis pathophysiology will be evaluated in all live births as well as during the follow-up, and when sepsis will be suspected. In addition, whole blood response to selected innate stimuli and extensive peripheral blood mononuclear cells phenotypic characterisation will be performed. Reference intervals specific to sub-Saharan neonates will be determined from this cohort and biomarkers performances for neonatal sepsis diagnosis and prognosis tested.
Ethical approval has been obtained from the Comité d'Ethique de la Recherche - Institut des Sciences Biomédicales Appliquées (CER-ISBA 85 - 5 April 2016, extended on 3 February 2017). Results will be disseminated through international presentations at scientific meetings and publications in peer-reviewed journals.
ClinicalTrials.gov registration number: NCT03780712.
新生儿败血症是全球范围内导致新生儿死亡的主要原因，在中低收入国家仍然是一个重大的社会负担。除了资源有限之外，地方性疾病，如疟疾和早产，通过改变新生儿对病原体的免疫反应，使新生儿和婴儿容易受到侵袭性感染。然而，对新生儿败血症的流行病学、诊断和免疫学评估以及妊娠疟疾的影响从未进行过深思熟虑的评估。
将在贝宁的城市和郊区对 580 名从出生到 3 个月大的婴儿进行前瞻性纵向多中心随访。在分娩时和每隔一周，所有儿童都将接受检查，并对发生败血症的情况进行临床评估。在分娩时，将对所有活产儿以及在随访期间和怀疑发生败血症时，对与败血症发病机制相关的选定血浆和转录组生物标志物（降钙素原、白细胞介素 (IL)-6、IL-10、IP10 和 ）进行系统分析。此外，还将对选定的先天刺激物的全血反应和广泛的外周血单个核细胞表型特征进行研究。将从该队列中确定适用于撒哈拉以南新生儿的参考区间，并测试生物标志物在新生儿败血症诊断和预后中的性能。
已获得研究伦理委员会 - 应用生物医学科学研究所（CER-ISBA 85-2016 年 4 月 5 日，2017 年 2 月 3 日延期）的批准。结果将通过在科学会议上的国际演讲和同行评议期刊上的发表进行传播。
ClinicalTrials.gov 注册号：NCT03780712。
