Glaser Kirsten, Rittenschober-Böhm Judith, Humberg Alexander, Stichtenoth Guido, Butzer Sarina, Mehler Katrin, Kipfmüller Florian, Köstlin-Gille Natascha, Gille Christian, Kick Andrea, Dornis Diana, Henrich Birgit, Farr Alex, Härtel Christoph, Silwedel Christine
Division of Neonatology, Department of Women's and Children's Health, University of Leipzig Medical Center, Leipzig, Germany.
Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics and Adolescent Medicine, Comprehensive Centre for Pediatrics, Medical University of Vienna, Vienna, Austria.
BMJ Open. 2025 Sep 2;15(9):e101442. doi: 10.1136/bmjopen-2025-101442.
Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on -associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with in very immature preterm infants born <29 weeks of gestation) study aims to assess the incidence of colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.
This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.
The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.
German Clinical Trials Register (DRKS00033001).
早产儿，尤其是那些在妊娠29周前出生的婴儿，发生支气管肺发育不良（BPD）和其他早产并发症的风险增加。大量证据表明，呼吸道被某种细菌定植会显著导致肺部炎症、肺功能受损以及随后的肺部疾病，尤其是在极不成熟的婴儿中。此外，这种细菌暴露与早产的其他炎症相关后遗症的发病机制有关。尽管这是一个可能对新生儿短期和长期不良结局产生影响的可干预风险因素，但关于这种细菌相关发病率的争议仍然存在，并且缺乏对早产儿筛查方法的建议。NEO-CONSCIOUS（妊娠<29周出生的极不成熟早产儿的细菌定植与感染）研究旨在评估不良结局风险高的极早产儿中该细菌定植和感染的发生率、潜在伴随炎症的程度以及对短期和长期发病率的影响。
这是一项在德国和奥地利的三级新生儿重症监护病房进行的前瞻性观察性多中心研究。总共400名妊娠29周前出生的婴儿在出生后立即接受该细菌定植的筛查。此外，在第1天和第28天测定全身炎症的生物标志物。对研究婴儿进行随访直至出院，并在矫正年龄2岁时进行随访。主要结局为在孕龄36周时评估BPD和/或死亡。次要结局包括全身炎症、继发性感染、脑室内出血、脑室周围白质软化、坏死性小肠结肠炎、早产儿视网膜病变以及矫正年龄24个月时的神经发育结局。
该研究已获得维尔茨堡和莱比锡的伦理委员会以及所有参与中心的当地伦理委员会的批准。结果将通过同行评审的国际出版物和会议进行传播。该研究已在德国临床试验注册中心注册，注册号为DRKS00033001。
德国临床试验注册中心（DRKS00033001）
