Intestinal Failure in Necrotising Enterocolitis
- Conditions
- Necrotizing Enterocolitis
- Registration Number
- NCT01441739
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- No written informed consent of both parents
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Urinary I-FABP Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands