Intestinal Failure in Necrotising Enterocolitis

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.

Study Overview

• Status: Unknown
• Conditions: Necrotizing Enterocolitis

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Kostan Reisinger, MD; Phone Number: +31433882125; Email: k.reisinger@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Kostan Reisinger, MD; Phone Number: +31433882125; Email: k.reisinger@maastrichtuniversity.nl
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • University Medical Center Utrecht
    • Contact: Hens Brouwers, MD, PhD; Phone Number: +31887554545; Email: h.a.a.brouwers@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Controls
NEC suspected - Final diagnosis NEC
NEC suspected - Final diagnosis no NEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary I-FABP	Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: MEC 04-197

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No