Intestinal Failure in Necrotising Enterocolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01441739
First received: September 21, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition
Necrotizing Enterocolitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Intestinal Failure in Necrotising Enterocolitis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Urinary I-FABP [ Time Frame: Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
NEC suspected - Final diagnosis NEC
NEC suspected - Final diagnosis no NEC
Controls

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441739

Contacts
Contact: Kostan Reisinger, MD +31433882125 k.reisinger@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Kostan Reisinger, MD    +31433882125    k.reisinger@maastrichtuniversity.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Hens Brouwers, MD, PhD    +31887554545    h.a.a.brouwers@umcutrecht.nl   
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01441739     History of Changes
Other Study ID Numbers: MEC 04-197
Study First Received: September 21, 2011
Last Updated: December 17, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014