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UnknownNCT00588718

A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis

Status
Unknown
Phase
Study type
Observational
Enrollment
740 (estimated)
Sponsor
R. Lawrence Moss · Academic / Other
Sex
All
Age
72 Hours – 28 Weeks
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2007-04-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2008-01-09
Last updated
2018-03-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00588718. Inclusion in this directory is not an endorsement.