Collaborative Research Group for Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Salivary EGF (Epidermal Growth Factor) Protein Levels
研究概览
简要总结
This proposal will test the hypothesis that synthesis and catabolism of epidermal growth factor (EGF), the genotype of the EGF gene, and the microbiome interact to influence EGF expression in infants at risk for necrotizing enterocolitis (NEC).
详细描述
- Preterm infants will receive a six hour intravenous infusion of [5,5,5-2H3]leucine (2H3) through an existing intravenous line (IV) to measure EGF synthesis rate.
- Two blood samples will be obtained, one prior to the start of infusion, and one during the infusion. The enrichment of the stable isotope labeled leucine will be measured in the plasma from these samples; DNA will be extracted from the residual cell pellets. The EGF and EGF receptor genes will be sequenced.
- Saliva and urine will be obtained for 5 days following infusion to measure EGF and the rate of incorporation of leucine into EGF using liquid chromatography (LC)/mass spectroscopy (MS)/MS technology, as well as enzyme-linked immunosorbent assay (ELISA) . Saliva will be obtained by a Q tip swab and urine and stool obtained from the diaper.
- Stool will be obtained every 3 to 7 days through 5 weeks to evaluate inflammatory markers and the microbiome.
- If breastfeeding, a single sample of mother's milk will be obtained for measurement of EGF after adequate volumes for infant feeds are achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestation 32 weeks or less
- •1 week of age or less
- •intravenous line in place for clinical purposes
排除标准
- •imminent death
- •active infection
- •pre-existing diagnosis of NEC
- •fluid or electrolyte imbalance
结局指标
主要结局
Salivary EGF (Epidermal Growth Factor) Protein Levels
时间窗: Sampling occurred on average day of life 9 with a range from day of life 7 to 21
Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R \&D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.
Urinary EGF Protein Levels
时间窗: Sampling occurred on average day of life 9 with a range from day of life 7 to 21
Urinary EGF protein levels obtained from free flowing urine samples retrieved from subject diaper were analyzed by commercially available EGF ELISA kit (R \&D systems Inc). EGF protein levels were normalized to milligrams of creatinine in urine, and expressed as nanograms of EGF protein per milligram of urinary creatinine.
次要结局
- EGF Gene Sequencing(Sampling occurred on average day of life 9 with a range from day of life 7 to 21)