APC Microbiome Ireland, University College Cork, Cork, Ireland
Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.
BMJ Open. 2023 Sep 25;13(9):e075060. doi: 10.1136/bmjopen-2023-075060.
Very preterm infants are at risk of abnormal microbiome colonisation in the first weeks to months of life. Several important associated factors have been identified including gestational age, mode of delivery, antibiotic exposure and feeding. Preterm infants are at risk of a number of pathologies for which the microbiome may play a central role, including necrotising enterocolitis and sepsis. The objective of this study is to determine detailed microbiome changes that occur around implementation of different management practices including empiric antibiotic use, advancement of feeds and administration of probiotics during admission to the neonatal intensive care unit.
A single-site, longitudinal observational study of infants born less than 32 weeks gestation, including collection of maternal samples around delivery and breastmilk and infant samples from admission through discharge from the neonatal unit.
The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.The findings from this study will be disseminated in peer-reviewed journals, during scientific conferences, and directly to the study participants. Sequencing data will be deposited in public databases.
NCT05803577.
极早产儿在生命的最初几周至几个月内存在异常微生物组定植的风险。已经确定了几个重要的相关因素，包括胎龄、分娩方式、抗生素暴露和喂养方式。早产儿易患多种与微生物组可能发挥核心作用的疾病，包括坏死性小肠结肠炎和败血症。本研究的目的是确定在新生儿重症监护病房入院期间实施不同管理措施（包括经验性使用抗生素、推进喂养和使用益生菌）时发生的详细微生物组变化。
这是一项单站点、纵向观察性研究，纳入胎龄小于 32 周的婴儿，包括分娩前后的产妇样本以及婴儿从入院到出院期间的母乳和婴儿样本。
该方案已获得科克教学医院临床研究伦理委员会的批准。本研究的结果将在同行评议的期刊、科学会议上以及直接向研究参与者传播。测序数据将被存入公共数据库。
NCT05803577。
