NIRS and Doppler to Predict NEC in Risk Neonates

NCT ID: NCT01833000

Last Updated: 2013-04-16

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

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

Brief Summary

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The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).

Detailed Description

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Conditions

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Necrotizing Enterolitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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newborn suspected to suffer from necrotizing enterolitis

Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

Group Type OTHER

Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

Intervention Type DEVICE

Interventions

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Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
* signed authorization by the parents (consent form)

Exclusion Criteria

* \- cutaneous lesions in the regions of monitoring
* emergency for NEC
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Cambonie, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Hospital of Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles Cambonie, MD PhD

Role: CONTACT

+33467336609

Facility Contacts

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Gilles Cambonie, MD,PhD

Role: primary

claire chauveton, pharmD

Role: backup

+33467330924

Other Identifiers

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9048

Identifier Type: -

Identifier Source: org_study_id

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