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A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

NCT00588718 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 740

Last updated 2018-03-09

No results posted yet for this study

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

  • Necrotizing Enterocolitis

Sponsors & Collaborators

Principal Investigators

  • R. Lawrence Moss, MD · Nationwide Children's Hospital, The Ohio State University

Eligibility

Min Age
72 Hours
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588718 on ClinicalTrials.gov