A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
- Conditions
- Necrotizing Enterocolitis
- Registration Number
- NCT00588718
- Lead Sponsor
- R. Lawrence Moss
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 740
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts. 4 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia
🇺🇸Columbus, Ohio, United States