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Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

This study has been terminated.
(Terminated: participants are no longer being enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062828
First Posted: February 4, 2010
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teresa del Moral, University of Miami
February 3, 2010
February 4, 2010
August 28, 2017
July 2009
July 2017   (Final data collection date for primary outcome measure)
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
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 NICU ]
Complete list of historical versions of study NCT01062828 on ClinicalTrials.gov Archive Site
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
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 ]
Not Provided
Not Provided
 
Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants
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.

The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Premature infants with gestational age between <32 weeks regardless of birth weight born at University of Miami/Holtz Children's Hospital Neonatal Intensive Care Unit, or transferred in within the first 72h of life.
  • Premature Newborn
  • Necrotizing Enterocolitis
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.
Gestational age < 32 weeks
Premature infants with gestational age between <32 weeks regardless of birth weight
Intervention: Diagnostic Test: Citrulline samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
July 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1. Premature infants with gestational age between <32 weeks regardless of birth weight

Exclusion Criteria:

  1. Inborn errors of metabolism
  2. Need for exchange transfusion
  3. Multiple congenital anomalies
  4. 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)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01062828
20081180
No
Not Provided
Plan to Share IPD: No
Teresa del Moral, University of Miami
University of Miami
Not Provided
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
University of Miami
August 2017