Intestinal Failure in Necrotising Enterocolitis

NCT ID: NCT01441739

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Necrotizing Enterocolitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NEC suspected - Final diagnosis NEC

No interventions assigned to this group

NEC suspected - Final diagnosis no NEC

No interventions assigned to this group

Controls

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Kostan Reisinger, MD

Role: CONTACT

Phone: +31433882125

Email: [email protected]

Facility Contacts

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Kostan Reisinger, MD

Role: primary

Hens Brouwers, MD, PhD

Role: primary

Other Identifiers

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MEC 04-197

Identifier Type: -

Identifier Source: org_study_id