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

NCT01062828 | Terminated

• 1 other identifier: 20081180
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Newborn; Necrotizing Enterocolitis

Keywords

Prematurity; Necrotizing Enterocolitis; Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  From birth until discharge from NICU

Study Arms (1)

Gestational age < 32 weeks

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

Diagnostic Test: Citrulline samples

Interventions

Citrulline samples 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.

Gestational age < 32 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Inborn errors of metabolism
• Need for exchange transfusion
• Multiple congenital anomalies
• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

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

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jennifer Garcia, MD

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

  STUDY DIRECTOR

• Teresa Del Moral, MD

  University of Miami, Dept of Pediatrics, Division of Neonatology

  PRINCIPAL INVESTIGATOR

• John Thompson, MD

  The Children's Hospital at Montefiore

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)