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 : March 9, 2018
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|
|Study Type :||Observational|
|Estimated Enrollment :||740 participants|
|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 2019|
|Estimated Study Completion Date :||December 2019|
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.
- 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
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|
|Principal Investigator:||R. Lawrence Moss, MD||Nationwide Children's Hospital, The Ohio State University|