Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae (Matrix Neonat)

October 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris
The purpose of the study is to determine whether tele-expertise would be more effective and more cost-effective for the Interpretation of MRI Among Neonates with high risk of neurological sequelae

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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
      • Le Kremlin Bicêtre, France, 94275
        • Service de radiopédiatrie
      • Paris, France, 75012
        • Service de Radiopédiatrie. Hôpital Trousseau
      • Paris, France, 75015
        • Service de radiopédiatrie. Hôpital Necker
      • Paris, France, 75019
        • Service de radiopédiatrie - Hôpital Robert Debré

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

Sampling Method

Non-Probability Sample

Study Population

Infants hospitalized in neonatology unit

Description

Inclusion Criteria:

  • Less than 28 days of life
  • Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed group, during Tele-expertise
Infants hospitalized in health facilities performing tele-expertise
Device: Infants hospitalized in health facilities performing Tele-expertise
Exposed group, Prior Tele-expertise
Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time between MRI and decision of intensive care continuation
Time Frame: 1 week after discharge
A cerebral MRI for neonates, prescribed by the ICU team, will be performed, requiring a specialist advice. This advice is mandatory for ICU team to decide the intensive care continuation.
1 week after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Time between MRI and the specialist report
Time Frame: 1 week after discharge
1 week after discharge
Time between MRI and the discussions with the parents
Time Frame: 1 week after discharge
1 week after discharge

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Elisabeth Dion, MD, PhD, Centre de téléradiologie, Assistance Publique, Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

January 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLM-MatrixNeonat

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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