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| Sponsors and Collaborators: |
Yale University Glaser Pediatric Research Network The Gerber Foundation Stanford University Baylor College of Medicine Children's Hospital Boston University of California, San Francisco University of California, Los Angeles Johns Hopkins University University of Pennsylvania |
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| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00588718 |
Purpose
Necrotizing enterocolitis (NEC)is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may break open, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.
In this study, in addition to clinical data collection, blood and urine samples from infants with NEC will be examined for patterns of proteins and/or genetic characteristics. It is hoped that it will be possible to diagnose and treat infants earlier in the disease process as well as to know which infants will progress to the severest form of NEC. Earlier treatment could lead to a better outcome for these babies.
| Condition |
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Necrotizing Enterocolitis |
| Study Type: | Observational |
| Study Design: | Case Control, Cross-Sectional |
| Official Title: | Cross-Sectional Pilot Study of Biologic Samples in Necrotizing Enterocolitis: Proteomics & Genomics Approach |
Blood Urine
| Estimated Enrollment: | 88 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2008 |
| Groups/Cohorts |
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Cases
Infants who meet the entry criteria
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Controls
Banked blood samples held at Stanford University Core Laboratory will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls.
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Inclusion Criteria:
Patients must meet at least one criterion from each of the following three categories to be enrolled into the study.
Historical Factors
Physical Examination Findings
Radiologic Findings
Exclusion Criteria:
Clinical Outcome Measures:
Final Outcome Measures:
Genomic and proteomic profiles will be matched to clinical outcomes
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Prematurely-born infants with necrotizing enterocolitis who meet study entry criteria
Inclusion Criteria:
Historical Factors
Physical Examination Findings
Radiologic Findings
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| R. Lawrence Moss, MD, Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | R. Lawrence Moss, MD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( R. Lawrence Moss, MD ) |
| Study ID Numbers: | 26128 |
| Study First Received: | January 3, 2008 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00588718 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Necrotizing enterocolitis Progressive necrotizing enterocolitis Proteomics in blood Genomics in blood Multi-center |
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Digestive System Diseases Gastrointestinal Diseases Necrotizing Enterocolitis Intestinal Diseases |
Gastroenteritis Enterocolitis, Necrotizing Enterocolitis |
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Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Gastroenteritis Enterocolitis, Necrotizing Enterocolitis |
