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

NCT ID: NCT01062828

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2017-07-31

Brief 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.

Detailed Description

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

Conditions

Premature Newborn; Necrotizing Enterocolitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Gestational age < 32 weeks

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

Citrulline samples

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Teresa del Moral

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Garcia, MD

Role: STUDY_DIRECTOR

University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition

Teresa Del Moral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami, Dept of Pediatrics, Division of Neonatology

John Thompson, MD

Role: STUDY_CHAIR

The Children's Hospital at Montefiore

Locations

Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital

Miami, Florida, United States

Countries

United States

Other Identifiers

20081180

Identifier Type: -

Identifier Source: org_study_id