Research of Diagnostic Value of Fecal miRNA and Intestinal Flora in Infants With BMJ
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Analysis of breast milk exosomes miRNA
研究概览
简要总结
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. But for a long time, BMJ diagnosis has relied on clinical exclusive methods, lack of objective and reliable laboratory indicators. Which leads to misdiag. This project is a single-center, prospective nested case-control study. It is planned to establish a neonatal BMJ cohort. According to the admission criteria, 100 cases of early-onset BMJ and late-onset BMJ will be completed, and 100 healthy controls collected during the same period. , Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis, and try to find the feasibility and practical value of diagnostic markers for feces in infants with BMJ.
详细描述
This project is a single-center, prospective nested case-control study to investigate feasibility and practical value of diagnostic markers in infants with BMJ.
According to the admission criteria, 100 cases of early-onset BMJ, 100 late-onset BMJ and 100 healthy controls will be selected. Their feces, peripheral venous blood and mothers' breast milk were collected for further testing. Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis.
This study is to find the objective and reliable laboratory indicators to diagnose BMJ.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Days 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following conditions must be met
- •Term newborns admitted to hospital with "neonatal hyperbilirubinemia"
- •Exclusive breastfeeding or mainly breastfeeding
- •Exclude perinatal infection, G-6P-D deficiency, homoimmune hemolysis, polycythemia, scalp hematoma, intracranial hemorrhage, cholestasis, hypoglycemia, hypothyroidism, hypothermia, neonatal asphyxia, fetus Pathological jaundice factors such as delayed stool excretion.
排除标准
- •As long as any one of the following conditions should be excluded
- •During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml.
- •Other pathological jaundice was diagnosed during the follow-up period.
- •Take probiotics during the sampling period.
- •The guardian asked to withdraw from the study halfway.
结局指标
主要结局
Analysis of breast milk exosomes miRNA
时间窗: 2021.10.01-2022.09.30
Analysis of breast milk exosomes miRNA
Analysis of newborn feces miRNA and intestinal flora analysis
时间窗: 2021.10.01-2022.09.30
Analysis of newborn feces miRNA and intestinal flora analysis
UGT1A1 test in newborn blood
时间窗: 2021.10.01-2022.09.30
UGT1A1 test in newborn blood
次要结局
未报告次要终点