Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
Matrix Neonat
1 other identifier
observational
70
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedOctober 16, 2018
September 1, 2018
3.8 years
September 24, 2018
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time between MRI and decision of intensive care continuation
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 Outcomes (2)
Time between MRI and the specialist report
1 week after discharge
Time between MRI and the discussions with the parents
1 week after discharge
Study Arms (2)
Exposed group, during Tele-expertise
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
Interventions
Eligibility Criteria
Infants hospitalized in neonatology unit
You may qualify if:
- Less than 28 days of life
- Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service de radiopédiatrie
Le Kremlin-Bicêtre, 94275, France
Service de Radiopédiatrie. Hôpital Trousseau
Paris, 75012, France
Service de radiopédiatrie. Hôpital Necker
Paris, 75015, France
Service de radiopédiatrie - Hôpital Robert Debré
Paris, 75019, France
Related Publications (2)
Larroque B, Ancel PY, Marret S, Marchand L, Andre M, Arnaud C, Pierrat V, Roze JC, Messer J, Thiriez G, Burguet A, Picaud JC, Breart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.
PMID: 18328928BACKGROUNDKidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
PMID: 22617736BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
October 16, 2018
Study Start
January 1, 2014
Primary Completion
October 1, 2017
Study Completion
January 1, 2018
Last Updated
October 16, 2018
Record last verified: 2018-09