Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants
Since the first description of citrulline as a potential marker for intestinal function in 1998, its use has been investigated in a variety of disease processes including Short Bowel Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections producing intestinal cytopathic effects like Adenovirus, and predicting rejection in intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.
The introduction of enteral nutrition in the premature infant is a process of trial and error, knowing that the immaturity of the gastrointestinal system may lead to frequent episodes of feeding intolerance. This is augmented by the fear of the development of necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the conditions mentioned above for which citrulline has proven clinically useful.
A normal pattern of citrulline production has not been established in the premature population. Previous studies have shown decreased levels of glutamine and arginine in premature infants up to 10 days prior to the development of necrotizing enterocolitis. Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism of citrulline.
The investigators therefore hypothesize that defining a normal pattern of citrulline production in the premature population may prove to be a clinically useful diagnostic tool to screen for gastrointestinal disease.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Florida
-
Miami、Florida、美国、33136
- Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
1. Premature infants with gestational age between <32 weeks regardless of birth weight
Exclusion Criteria:
- Inborn errors of metabolism
- Need for exchange transfusion
- Multiple congenital anomalies
- Renal failure (defined as urine output <1ml/k/h >24h, creatinine >1.8, or diagnosis of "non-oliguric renal failure" as determined by Pediatric nephrology)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Gestational age < 32 weeks
Premature infants with gestational age between <32 weeks regardless of birth weight
|
Citrulline samples will be collected at the time of other lab work twice a week from enrollment until 40 weeks postconceptional age and once a week until 44 weeks postconceptional age (1 month corrected age) OR discharge from NICU(whichever is soonest).
In subgroup developing NEC, citrulline samples will be collected twice a week from enrollment until discharge from NICU or death.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The primary outcome is to establish the normal pattern of citrulline concentration in the premature population, infants born <32 weeks gestation, which represents normal maturity of the intestinal glutamine pathway.
大体时间:From birth to one month corrected age (Gestational age 44 weeks) or discharge from neonatal intensive care unit (NICU)
|
Levels of citrulline concentration in premature infants
|
From birth to one month corrected age (Gestational age 44 weeks) or discharge from neonatal intensive care unit (NICU)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
A secondary outcome, in the subgroup of infants who develop necrotizing enterocolitis, will be to evaluate the pattern of citrulline concentration prior to its development.
大体时间:From birth until discharge from NICU
|
levels of citrulline concentration in prematureinfants with NEC
|
From birth until discharge from NICU
|
合作者和调查者
调查人员
- 研究主任:Jennifer Garcia, MD、University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
- 首席研究员:Teresa Del Moral, MD、University of Miami, Dept of Pediatrics, Division of Neonatology
- 学习椅:John Thompson, MD、The Children's Hospital at Montefiore
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Citrulline samples的临床试验
-
Centre Hospitalier Universitaire de Saint Etienne完全的