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 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.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Florida
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Miami, Florida, 미국, 33136
- Holtz Children's Hospital- University of Miami/Jackson Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
1. Premature infants with gestational age between <32 weeks regardless of birth weight
Exclusion Criteria:
- 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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Gestational age < 32 weeks
Premature infants with gestational age between <32 weeks regardless of birth weight
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: From birth to one month corrected age (Gestational age 44 weeks) or discharge from neonatal intensive care unit (NICU)
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Levels of citrulline concentration in premature infants
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From birth to one month corrected age (Gestational age 44 weeks) or discharge from neonatal intensive care unit (NICU)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: From birth until discharge from NICU
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levels of citrulline concentration in prematureinfants with NEC
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From birth until discharge from NICU
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공동 작업자 및 조사자
수사관
- 연구 책임자: Jennifer Garcia, MD, University of Miami, Dept of Pediatrics, Division of GI, Hepatology and Nutrition
- 수석 연구원: Teresa Del Moral, MD, University of Miami, Dept of Pediatrics, Division of Neonatology
- 연구 의자: John Thompson, MD, The Children's Hospital at Montefiore
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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