Intestinal Failure in Necrotising Enterocolitis

Intestinal Failure in Necrotising Enterocolitis

Sponsors

Lead Sponsor: Maastricht University Medical Center

Source 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.

Overall Status Unknown status
Start Date September 2004
Completion Date September 2016
Primary Completion Date September 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Urinary I-FABP Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC
Enrollment 300
Condition
Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Kostan Reisinger, MD

Phone: +31433882125

Email: [email protected]

Location
Facility: Status: Contact:
Maastricht University Medical Center | Maastricht, 6229 HX, Netherlands Recruiting Kostan Reisinger, MD +31433882125 [email protected]
University Medical Center Utrecht | Utrecht, 3584 CX, Netherlands Recruiting Hens Brouwers, MD, PhD +31887554545 [email protected]
Location Countries

Netherlands

Verification Date

December 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: NEC suspected - Final diagnosis NEC

Label: NEC suspected - Final diagnosis no NEC

Label: Controls

Study Design Info

Observational Model: Case Control

Time Perspective: Prospective

Source: ClinicalTrials.gov