A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

NCT00588718 | Unknown

• 1 other identifier: 26128
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.

  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.

  4 years

Study Arms (2)

Cases

Infants who meet the entry criteria

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.

Eligibility Criteria

• Age: 72 Hours - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria

Sponsors & Collaborators

• R. Lawrence Moss: lead
• Mallinckrodt: collaborator
• Stanford University: collaborator
• Baylor College of Medicine: collaborator
• Johns Hopkins University: collaborator
• University of Pennsylvania: collaborator
• Yale University: collaborator

Study Sites (1)

R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 18784730 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• R. Lawrence Moss, MD

  Nationwide Children's Hospital, The Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon In Chief

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 9, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

US (1)