Matrix Neonat: Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT03706651
Collaborator
Agence Regionale de Sante d'Ile de France (Other)
70
4
48
17.5
0.4
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
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
:
Jan 1, 2014
Actual Primary Completion Date
:
Oct 1, 2017
Actual Study Completion Date
:
Jan 1, 2018
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- Time between MRI and decision of intensive care continuation [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
- Time between MRI and the specialist report [1 week after discharge]
- Time between MRI and the discussions with the parents [1 week after discharge]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de radiopédiatrie | Le Kremlin Bicêtre | France | 94275 | |
| 2 | Service de Radiopédiatrie. Hôpital Trousseau | Paris | France | 75012 | |
| 3 | Service de radiopédiatrie. Hôpital Necker | Paris | France | 75015 | |
| 4 | 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
- 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 Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Kidholm 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.
- Larroque B, Ancel PY, Marret S, Marchand L, André M, Arnaud C, Pierrat V, Rozé JC, Messer J, Thiriez G, Burguet A, Picaud JC, Bréart 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.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03706651
Other Study ID Numbers:
- TLM-MatrixNeonat
First Posted:
Oct 16, 2018
Last Update Posted:
Oct 16, 2018
Last Verified:
Sep 1, 2018