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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062828
• Other study ID #: 20081180
• Status: Terminated
• Phase: N/A
• First received: February 3, 2010
• Last updated: August 24, 2017
• Start date: July 2009
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Digestive System Diseases
• Enterocolitis
• Enterocolitis, Necrotizing
• Gastrointestinal Diseases
• Necrotizing Enterocolitis
• Premature Birth
• Premature Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Secondary	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.	levels of citrulline concentration in prematureinfants with NEC	From birth until discharge from NICU