Intestinal Failure in Necrotising Enterocolitis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01441739

Enrollment

300

Registered

2011-09-28

Start date

2004-09-30

Completion date

2016-09-30

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

Primary ContactKostan Reisinger, MD

k.reisinger@maastrichtuniversity.nl+31433882125

Outcome results