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

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ClinicalTrials.gov Identifier: NCT03706651
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Agence Regionale de Sante d'Ile de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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

Condition or disease Intervention/treatment
Hypoxia, Brain Device: Infants hospitalized in health facilities performing Tele-expertise

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
Study Start Date : January 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : January 2018

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time between MRI and the specialist report [ Time Frame: 1 week after discharge ]
  2. Time between MRI and the discussions with the parents [ Time Frame: 1 week after discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants hospitalized in neonatology unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706651


Locations
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France
Service de radiopédiatrie
Le Kremlin Bicêtre, France, 94275
Service de Radiopédiatrie. Hôpital Trousseau
Paris, France, 75012
Service de radiopédiatrie. Hôpital Necker
Paris, France, 75015
Service de radiopédiatrie - Hôpital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Agence Regionale de Sante d'Ile de France
Investigators
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Principal Investigator: Elisabeth Dion, MD, PhD Centre de téléradiologie, Assistance Publique, Hôpitaux de Paris
Principal Investigator: Isabelle Durand-Zaleski, MD, PhD DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03706651    
Other Study ID Numbers: TLM-MatrixNeonat
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Hypoxia, Brain
Hypoxia
Signs and Symptoms, Respiratory
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases