A Biologic Validation of Biomarkers of Progressive NEC & Sepsis (NEC)
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 perforate, 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, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis|
- To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Study has been amended/extended. Test the NEC diagnostic panel for its ability to distinguish NEC from SIP. Develop validated biomarkers on biosensors in preparation for prospective validation studies.
Independent prospective validation of biosensor based biomarker panels.
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Infants who meet the entry criteria
Banked blood samples from newborns who do not meet inclusion criteria for this study will be held at Stanford University Core Laboratory and will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588718
|United States, Ohio|
|R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia|
|Columbus,, Ohio, United States, 43205|
|Principal Investigator:||R. Lawrence Moss, MD||Nationwide Children's Hospital, The Ohio State University|