The Neonatal Microbiome and Necrotizing Enterocolitis. The Neonatal Microbiome and Necrotizing Enterocolitis

The Neonatal Microbiome and Necrotizing enterocolitis (NEC) study is a multi-centered case control study testing the hypothesis that NEC is a direct or indirect consequence of the enteric biomass, its products, or both. Very low birth weight infants (VLBW; birth weight <= 1500 grams) admitted to the neonatal intensive care unit are prospectively followed over the first 5 week or until they reach 36 weeks gestation, whichever occurs later. VLBW infants with a lethal clinical condition are excluded. Over the course of the study period, prospective samples are obtained on all infants, and include all stools, and weekly blood samples, palm and oral swabs. Clinical data is collected over the course of the entire hospitalization. Cases are identified based on Bell's staging for NEC, requiring Bell's stage II (abdominal clinical signs and radiographic evidence of pneumatosis, portal venous gas or pneumoperitoneum). Controls are identified from the pool of prospectively... (for more see dbGaP study page.)

新生儿微生物组与坏死性小肠结肠炎（Necrotizing enterocolitis, NEC）研究是一项多中心病例对照研究，旨在验证“坏死性小肠结肠炎是肠道微生物群及其代谢产物，或二者共同作用的直接或间接结果”这一假说。本研究前瞻性随访收入新生儿重症监护室的极低出生体重儿（Very low birth weight infants, VLBW，出生体重≤1500克），随访周期为出生后前5周，或直至其胎龄达到36周，以二者中较晚发生者为准。合并致命性临床病症的极低出生体重儿被排除出本研究。研究期间将采集所有入组婴儿的前瞻性样本，包括全部粪便样本、每周采集的血液样本，以及手掌和口腔拭子样本。临床数据收集将覆盖患儿整个住院周期。病例组依据贝尔（Bell）坏死性小肠结肠炎分期标准进行判定，需符合贝尔Ⅱ期标准，即存在腹部临床症状及影像学证据（如肠壁积气、门静脉积气或气腹）。对照组从前瞻性入组的婴儿队列中选取……（更多详情请参见dbGaP研究页面）。