A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- R. Lawrence Moss
- Enrollment
- 740
- Locations
- 1
- Primary Endpoint
- To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
- Last Updated
- 8 years ago
Overview
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.
Investigators
R. Lawrence Moss
Surgeon In Chief
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
Time Frame: 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.