Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants
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|ClinicalTrials.gov Identifier: NCT01062828|
Recruitment Status : Terminated (Terminated: participants are no longer being enrolled)
First Posted : February 4, 2010
Last Update Posted : August 28, 2017
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.
|Condition or disease||Intervention/treatment|
|Premature Newborn Necrotizing Enterocolitis||Diagnostic Test: Citrulline samples|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Gestational age < 32 weeks
Premature infants with gestational age between <32 weeks regardless of birth weight
Diagnostic Test: Citrulline samples
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.
- 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. [ Time Frame: 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
- 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. [ Time Frame: From birth until discharge from NICU ]levels of citrulline concentration in prematureinfants with NEC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062828
|United States, Florida|
|Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|Study Director:||Jennifer Garcia, MD||University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition|
|Principal Investigator:||Teresa Del Moral, MD||University of Miami, Dept of Pediatrics, Division of Neonatology|
|Study Chair:||John Thompson, MD||The Children's Hospital at Montefiore|