A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Necrotizing Enterocolitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Infants who meet the entry criteria

No interventions assigned to this group

Controls

Banked blood samples from newborns who do not meet inclusion criteria for this study will be held at Stanford University Core Laboratory and will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

72 Hours

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No