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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01062828
First received: February 3, 2010
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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 Intervention
Prematurity
Necrotizing Enterocolitis
Feeding Intolerance
Procedure: Citrulline samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gestational age < 32 weeks
Premature infants with gestational age between <32 weeks regardless of birth weight
Procedure: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062828

Contacts
Contact: Jennifer Garcia, MD 305-243-3166 JGarcia2@med.miami.edu
Contact: Teresa Del Moral, MD, MPH 305-243-4531 TDelMoral@med.miami.edu

Locations
United States, Florida
Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Jennifer Garcia, MD    305-243-3166    JGarcia2@med.miami.edu   
Contact: Teresa Del Moral, MD, MPH    305-243-4531    TDelMoral@med.miami.edu   
Sub-Investigator: Jennifer Garcia, MD         
Principal Investigator: Teresa Del Moral, MD, MPH         
Sponsors and Collaborators
University of Miami
Investigators
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
  More Information

No publications provided

Responsible Party: Teresa Del Moral MD, MPH, University of Miami, Department of Pediatrics, Division of Neonatology
ClinicalTrials.gov Identifier: NCT01062828     History of Changes
Other Study ID Numbers: 20081180
Study First Received: February 3, 2010
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Prematurity
Necrotizing Enterocolitis
Feeding Intolerance

Additional relevant MeSH terms:
Enterocolitis
Gastrointestinal Diseases
Digestive System Diseases
Enterocolitis, Necrotizing
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on August 18, 2014