An Exploratory Study of Increased 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
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Gene expression via Illumina RNA sequencing
研究概览
简要总结
PAINT18 is a nutrition study focusing on the effect of arginine supplementation on immune function in preterm infants.
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. The investigators will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 24 very premature infants receiving PN. 16 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 30 days of life. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and IGF-1 levels. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants
The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.
详细描述
Title The effect of increased Preterm Arginine INTake on biological pathways affecting immune function in infants requiring early parenteral nutrition (PAINT-18 )
Population Preterm infants <29 weeks gestation and/or <1200g
Number of infants 24 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.
Study duration Informed consent will take place antenatally, where possible, or within 72 hours of birth. The first study related blood sample will be taken on day 3 of life with the last sample taken on day 30 of life. Other study assessments reflect those routinely performed in preterm infants receiving parenteral nutrition (PN).
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
盲法说明
This is not blinded or randomized.
入排标准
- 年龄范围
- 22 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born <29 weeks' gestation
- •and/or with birthweight <1200g
- •Admitted to the Neonatal Unit at Liverpool Women's Hospital within 48 hours of birth.
排除标准
- •Infants who are unlikely to survive the first week after birth.
- •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
结局指标
主要结局
Gene expression via Illumina RNA sequencing
时间窗: Day 3 and 10 of life
RNA will be extracted from whole blood and sent for Illumina RNA sequencing. These sequences are then mapped to reference gene sets for gene expression analysis. The pattern of alteration in gene expression between days 3 and 10 in arginine deficient preterm infants after correction of their deficiency by supplementation with arginine will be analysed. The changes in gene expression will be compared with those seen in unsupplemented infants. The genes of interest are those involved in T-cell function and associated inflammatory pathways. Statistical pathway analysis will be used to identify these genes and their relationship with key biological pathways.
次要结局
- Blood ammonia levels(Day 3, 10 and 30 of life)
- Plasma arginine levels(Day 3, 10 and 30 of life)
- Plasma proline levels(Day 3, 10 and 30 of life)
- Body composition measuring total body fluid measured in litres(Day 3, 10 and 30 of life)
- Body composition measuring fat free mass in grams(Day 3, 10 and 30 of life)
- Growth measuring body weight in grams(Day 3, 10 and 30)
- Gene expression via Illumina RNA sequencing(Day 3, 10 and 30 of life)