NIRS and Doppler to Predict NEC in Risk Neonates (NeoNIRS)

April 11, 2013 updated by: University Hospital, Montpellier

Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • University Hospital of Montpellier
        • Contact:
        • Principal Investigator:
          • gilles Cambonie, MD,PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: newborn suspected to suffer from necrotizing enterolitis
Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler
Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebro-splanchnic oxygenation ratio
Time Frame: up to 48h
NIRS assessment
up to 48h

Secondary Outcome Measures

Outcome Measure
Time Frame
Mesenteric Doppler flow
Time Frame: up to 48h
up to 48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Gilles Cambonie, MD,PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9048 (CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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