A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | April 2007 |
| End Date: | December 2019 |
A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
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.
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.
Inclusion Criteria - NEC/Sepsis Cohort GA < 29 weeks Current age equal or <12 weeks
Suspicion of NEC or Sepsis
Exclusion - NEC/Sepsis Cohort Current or prior diagnosis of NEC Early onset infection
(equal or <72 hours of life) Previous diagnosis of sepsis within 7 days Previous abdominal
surgery Significant congenital anomaly
Inclusion Criteria - SIP Cohort Infants born at <29 weeks gestation Equal to or <12 weeks
of age at the time of eligibility assessment a decision to perform surgery (or drain) for
suspected NEC or SIP
Exclusion - SIP Cohort Congenital infection (Equal to <72 hours of life) Prior episode of
NEC or SIP Prior laparotomy or drain for SIP or NEC
We found this trial at
1
site
Columbus, Ohio 43205
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