Clinical trial NCT00588718: A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
Official title: A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis
Keywords: Necrotizing enterocolitis
Progressive necrotizing enterocolitis
Proteomics in blood
Genomics in blood
Multi-center
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
name: Stanford University
name: Baylor College of Medicine
name: Johns Hopkins University
name: University of Pennsylvania
name: Yale University
First posted: 2008-01-09
Enrollment: 740
Sex: ALL
Minimum age (years): 72
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria

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.


Eligibility 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

Primary outcomes:
measure: To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital, The Ohio State University
name: R. Lawrence Moss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moss RL, Kalish LA, Duggan C, Johnston P, Brandt ML, Dunn JC, Ehrenkranz RA, Jaksic T, Nobuhara K, Simpson BJ, McCarthy MC, Sylvester KG. Clinical parameters do not adequately predict outcome in necrotizing enterocolitis: a multi-institutional study. J Perinatol. 2008 Oct;28(10):665-74. doi: 10.1038/jp.2008.119. Epub 2008 Sep 11.