Gastrointestinal Microbiota Influence on the Pathogenesis of Bronchopulmonary Dysplasia in Very Low Birthweight Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Bronchopulmonary dysplasia (BPD)
研究概览
简要总结
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria that naturally live in the gut, and determine if the relative diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the investigators propose to characterize the microbiota of human premature newborns with BPD, then validate this potential mechanism in mice. The investigators will enroll very low birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be obtained weekly over the first month of life. Infants that eventually develop BPD will be paired with infants that did not develop BPD. Stool samples from these infants will be sent for analysis. The investigators expect that reduced complexity of the gut microbiome is associated with BPD. The investigators will model the contribution of reduced microbiome complexity to the risk to develop BPD or death, as well as the association with disease severity. The project investigates important factors leading to the development of BPD, and has the potential to directly translate to therapy for the most significant pulmonary complication of prematurity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn humans less than 1 week of age with a birthweight less than 1,500 g, or fetuses with impending delivery and estimated birthweight of less than 1,500 grams. No individuals will be excluded on the basis of sex or ethnicity.
- •Parents can understand and comply with planned study procedures.
- •Parents provide assent/permission prior to any study procedures.
- •Inclusion criteria mothers:
- •The mother's of infants meeting the infant inclusion criteria above.
排除标准
- •Diagnosed immunodeficiency disorder.
- •Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
- •Infants whose mothers meet the exclusion criteria below.
- •Exclusion criteria mothers:
- •Diagnosed immunodeficiency disorder
- •Currently receiving investigational immunomodulatory, probiotic or antiviral agents
- •Lacking the mental capacity (e.g. due to pain, anesthesia, mental impairment) to provide informed consent for themselves or assent for the participation of their infant.
- •Having an infant that meets the infant exclusion criteria.
结局指标
主要结局
Bronchopulmonary dysplasia (BPD)
时间窗: 36 weeks corrected gestational age, until the date of death or initial hospital discharge whichever occurs first, assessed up to up to 3 months
National Institute of Child Health and Disease (NICHD) consensus definition
Death
时间窗: from the date of enrollment until the date of death or initial hospital discharge, whichever occurs first, assessed up to up to 3 months
次要结局
- Maternal Chorioamnionitis(presence on admission)
- Necrotizing Enterocolitis (NEC)(from the date of enrollment until the date of initial hospital discharge or death, whichever occurs first, assessed up to up to 3 months)
研究者
Kent Avery Willis, MD
Neonatal-Perinatal Medicine Fellow
University of Tennessee