Intestinal Failure in Necrotising Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

Intestinal Failure in Necrotising Enterocolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01441739
• Other study ID #: MEC 04-197
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2011
• Last updated: December 17, 2013
• Start date: September 2004
• Est. completion date: September 2016

Study information

• Verified date: December 2013
• Source: Maastricht University Medical Center
• Contact: Kostan Reisinger, MD
• Phone: +31433882125
• Email: k.reisinger[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary I-FABP		Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC	No