Effect of Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The pattern of alteration in gene expression between day 3 and day 10 in arginine deficient preterm infants after supplementation with arginine.
研究概览
简要总结
The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. They will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants will be supplemented with arginine. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 10 days of life. They will take blood for analysis at prespecified intervals for microarray, ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants.
详细描述
Title:
Effect of Preterm Arginine INTake on biological pathways affecting immune function in infants requiring early parenteral nutrition (PAINT)
Population: Preterm infants <29 weeks gestation
Number of infants: 12 infants (completing the study) will be recruited over approximately 12 months
Number of sites: One. Infants will be born at Liverpool Women's Hospital (LWH) or transferred to LWH within 48 hours of birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth
排除标准
- •Infants who are unlikely to survive the first week after birth.
- •Infants with early onset infection (<72 hours)
- •Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction
- •Parents who are unable to give informed consent
研究组 & 干预措施
Low Arginine unsupplemented
These infants identified as having low blood arginine levels will receive standard care.
Normal Arginine
These infants identified as having normal arginine levels will receive standard care.
Low Arginine supplemented
These infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life.
干预措施: Arginine (Dietary Supplement)
结局指标
主要结局
The pattern of alteration in gene expression between day 3 and day 10 in arginine deficient preterm infants after supplementation with arginine.
时间窗: Samples on Day 3 and Day 10 of life
The changes in gene expression will be compared with those seen in unsupplemented infants, with and without arginine deficiency. The genes of interest are those involved in T-cell function and associated inflammatory pathways.
次要结局
- The pattern of alteration in gene expression associated with biological pathways known to be associated with NEC.(Day 3 and Day 10 of life)
- To validate if high ammonia levels (as a measure of functional arginine deficiency) are linked with impaired T-cell function and associated inflammatory pathways(Day 3 of life)
- The pattern of alteration in gene expression associated with biological pathways known to be involved in arginine metabolism(Day 3 and Day 10 of life)
- The pattern of alteration in gene expression associated with biological pathways that are related to the IGF-1-insulin axis(Day 3 and Day 10 of life)