A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

R. Lawrence Moss

Status: Unknown

Conditions: Necrotizing Enterocolitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00588718

26128

Details and patient eligibility

About

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.

Enrollment: 740 estimated patients

Sex: All

Ages: 72 hours to 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

740 participants in 2 patient groups

Cases

Description:

Infants who meet the entry criteria

Controls

Description:

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.