NCT01441739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

12 years

First QC Date

September 21, 2011

Last Update Submit

December 17, 2013

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

  • Urinary I-FABP

    Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC

Study Arms (3)

NEC suspected - Final diagnosis NEC

NEC suspected - Final diagnosis no NEC

Controls

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • No written informed consent of both parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Kostan Reisinger, MD

CONTACT

+31433882125k.reisinger@maastrichtuniversity.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 28, 2011

Study Start

September 1, 2004

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

NL(2)