A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

Necrotizing Enterocolitis Clinical Trial

— NEC  

Official title:

A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00588718
• Other study ID #: 26128
• Status: Active, not recruiting
• Phase: N/A
• First received: January 3, 2008
• Last updated: March 8, 2018
• Start date: April 2007
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 740
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
United States	R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia	Columbus	Ohio

Sponsors (7)

Lead Sponsor	Collaborator
R. Lawrence Moss	Baylor College of Medicine, Johns Hopkins University, Mallinckrodt, Stanford University, University of Pennsylvania, Yale University

Country where clinical trial is conducted

United States, 

References & 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 Pe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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