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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588718
First Posted: January 9, 2008
Last Update Posted: February 17, 2017
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.
Collaborators:
Mallinckrodt
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
January 3, 2008
January 9, 2008
February 17, 2017
April 2007
December 2018   (Final data collection date for primary outcome measure)
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.

Proteomic and genomic profiles will be matched to NEC clinical endpoints [ Time Frame: April 2007 to December, 2008 ]
Complete list of historical versions of study NCT00588718 on ClinicalTrials.gov Archive Site
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A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis

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.

Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
Blood and Urine
Non-Probability Sample
Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria
Necrotizing Enterocolitis
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
740
December 2018
December 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
up to 28 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588718
26128
No
Not Provided
Not Provided
R. Lawrence Moss, Nationwide Children's Hospital
R. Lawrence Moss
  • Mallinckrodt
  • 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
Nationwide Children's Hospital
February 2017
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