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A Biologic Validation of Biomarkers of Progressive NEC & Sepsis (NEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588718
Recruitment Status : Active, not recruiting
First Posted : January 9, 2008
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Necrotizing Enterocolitis

Study Design

Study Type : Observational
Estimated Enrollment : 740 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
Actual Study Start Date : April 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts

Infants who meet the entry criteria
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.

Outcome Measures

Primary Outcome Measures :
  1. To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts. [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Blood and Urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588718

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
Stanford University
Baylor College of Medicine
Johns Hopkins University
University of Pennsylvania
Yale University
Principal Investigator: R. Lawrence Moss, MD Nationwide Children's Hospital, The Ohio State University
More Information

Responsible Party: R. Lawrence Moss, Surgeon In Chief, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00588718     History of Changes
Other Study ID Numbers: 26128
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by R. Lawrence Moss, Nationwide Children's Hospital:
Necrotizing enterocolitis
Progressive necrotizing enterocolitis
Proteomics in blood
Genomics in blood

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