A Cohort Study of the Intestinal Microbiota of Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnosis of necrotizing enterocolitis
研究概览
简要总结
Premature infants are at risk for a variety of diseases, the investigators would like to learn more about why some premature babies are at higher risk and some are protected from these diseases.
Scientists at UC Davis and other universities have developed new ways to measure the bacteria and a large number of small molecules in specimens of infant blood, urine, stomach fluid and poop and in mother's milk. These discoveries allow us to consider questions that were impossible to answer before these new techniques were developed. One such question is whether the bacteria in the poop of a premature baby can help us predict the baby's risk for developing infection or a common and serious disease of premature infants called necrotizing enterocolitis. A second question is whether the DNA of a premature baby (obtained from saliva with a q-tip) can predict higher risk for diseases of premature babies.
详细描述
Samples from eligible infants will be collected and stored for future comparisons. These samples include stool specimens from a messy diaper twice weekly, urine samples from cotton balls in the diaper once weekly, a small sample of stomach fluid once a week just prior to a feeding obtained through the feeding tube, a sample of mom's milk once a week, left-over blood from lab draws, and a sample of saliva on one occasion.
The analysis of key specimens from this cohort will allow us to study the impact of the bacteria in the intestines on outcomes like growth and common diseases of premature infants.
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
- — 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age < 33 weeks at birth
排除标准
- 未提供
结局指标
主要结局
Diagnosis of necrotizing enterocolitis
时间窗: up to 20 weeks, from the time of enrollment until the time of discharge from the neonatal intensive care unit (NICU)
How many infants in the cohort develop stage 2 or stage 3 necrotizing enterocolitis by Bells modified criteria
次要结局
- Diagnosis of growth failure(up to 20 weeks, from the time of enrollment until the time of discharge from the NICU)
- Diagnosis of bronchopulmonary dysplasia(up to 20 weeks, from the time of enrollment until the time of discharge from the NICU)