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A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Ikaria Holdings Inc.
Stanford University
Baylor College of Medicine
Johns Hopkins University
University of Pennsylvania
Yale University
Information provided by (Responsible Party):
R. Lawrence Moss, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00588718
First received: January 3, 2008
Last updated: February 12, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Necrotizing Enterocolitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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.



Biospecimen Retention:   Samples With DNA

Blood and Urine


Estimated Enrollment: 740
Study Start Date: April 2007
Estimated Study Completion Date: December 2014
Groups/Cohorts
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

Ages Eligible for Study:   up to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588718

Locations
United States, Ohio
R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia
Columbus,, Ohio, United States, 43205
Sponsors and Collaborators
R. Lawrence Moss
Ikaria Holdings Inc.
Stanford University
Baylor College of Medicine
Johns Hopkins University
University of Pennsylvania
Yale University
Investigators
Principal Investigator: R. Lawrence Moss, MD Nationwide Children's Hospital, The Ohio State University
  More Information

Publications:

Responsible Party: R. Lawrence Moss, Surgeon In Chief, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00588718     History of Changes
Other Study ID Numbers: 26128
Study First Received: January 3, 2008
Last Updated: February 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Necrotizing enterocolitis
Progressive necrotizing enterocolitis
Proteomics in blood
Genomics in blood
Multi-center

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 17, 2012