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NCT01062828 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Miami.

Terminated
Registry status
60
Enrollment target

NCT01062828: Clinical Trial study, sponsored by University of Miami.

NCT01062828 is a clinical trial that was terminated before completion, run by University of Miami. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01062828 was terminated before completion, sponsored by University of Miami.

TERMINATED
Registry status
60 participants
Enrollment target

Study 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.

Primary Outcome

Levels of citrulline concentration in premature infants

Interventions

  • DIAGNOSTIC_TEST Citrulline samples

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2009-07
Est. Completion 2017-07
University of Miami

721 total trials

Why NCT01062828 stopped before completion

NCT01062828 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Citrulline samples is the first listed.

NCT01062828 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01062828 about?

NCT01062828 is a clinical study titled "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 cytop...

What is the current status of trial NCT01062828?

This trial is currently terminated. The enrollment target is 60 participants. The study started on 2009-07. Estimated completion is 2017-07.

What interventions are being tested in trial NCT01062828?

The interventions under investigation include: Citrulline samples (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT01062828?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01062828, the US trial registry maintained by the National Library of Medicine. NCT01062828 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.