A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00588718

Acronym

NEC

Enrollment

740

Registered

2008-01-09

Start date

2007-04-30

Completion date

2019-12-31

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing enterocolitis, Progressive necrotizing enterocolitis, Proteomics in blood, Genomics in blood, Multi-center

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

72 Hours to 28 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.	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.

Countries

United States

Outcome results