Premature NewbornNCT01062828
Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants
An observational study of Premature Newborn and Necrotizing Enterocolitis, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Newborn, Necrotizing Enterocolitis
- What is being tested?
- Citrulline samples
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 1. Premature infants with gestational age between <32 weeks regardless of birth weight
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136
About this study
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.
Read more
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.
Read the 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
- Being tested
- Citrulline samples
- Keywords
- Prematurity, Necrotizing Enterocolitis, Feeding Intolerance
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrulline samplesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Gestational age < 32 weeks | Premature infants with gestational age between <32 weeks regardless of birth weight Receives: Diagnostic Test: Citrulline samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
levels of citrulline concentration in prematureinfants with NEC
Measured: From birth until discharge from NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Terminated: participants are no longer being enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa del Moral, University of Miami
- Investigators
- Jennifer Garcia, MD, Study director, University of Miami, Dept of Pediatrics, Division of GI, Hepatology and NutritionTeresa Del Moral, MD, Principal investigator, University of Miami, Dept of Pediatrics, Division of NeonatologyJohn Thompson, MD, Study chair, Children's Hospital at Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062828
- Sponsor's protocol ID
- 20081180
- Status last verified
- Aug 2017
- First submitted
- 3 Feb 2010
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants
- ClinicalTrials.gov ID
- NCT01062828
- Acronym / sponsor ID
- 20081180
- Conditions
- Premature Newborn, Necrotizing Enterocolitis
- Keywords
- Prematurity, Necrotizing Enterocolitis, Feeding Intolerance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated: participants are no longer being enrolled
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational age < 32 weeks | – | Diagnostic Test: Citrulline samplesPremature infants with gestational age between <32 weeks regardless of birth weight |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Premature infants with gestational age between <32 weeks regardless of birth weight
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrulline samplesCitrulline 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. | Diagnostic test | Gestational age < 32 weeks |
Primary outcome
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)
Levels of citrulline concentration in premature infants
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Terminated: participants are no longer being enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Garcia, MD study director
University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
Teresa Del Moral, MD principal investigator
University of Miami, Dept of Pediatrics, Division of Neonatology
John Thompson, MD study chair
Children's Hospital at Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Newborn and Necrotizing Enterocolitis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated: participants are no longer being enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.