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Clinical Trials/NCT01441739
NCT01441739
Unknown
Not Applicable

Intestinal Failure in Necrotising Enterocolitis

Maastricht University Medical Center2 sites in 1 country300 target enrollmentSeptember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Necrotizing Enterocolitis
Sponsor
Maastricht University Medical Center
Enrollment
300
Locations
2
Primary Endpoint
Urinary I-FABP
Last Updated
12 years ago

Overview

Brief Summary

Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis.

The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
September 2016
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Neonates with abdominal signs suspected of NEC
  • All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008

Exclusion Criteria

  • No written informed consent of both parents

Outcomes

Primary Outcomes

Urinary I-FABP

Time Frame: Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC

Study Sites (2)

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