Clinical Trials Logo
  1. Home
  2. Hypoxia, Brain
  3. NCT03706651
  4. Details
NCT03706651 Clinical Trial

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

Hypoxia, Brain Clinical Trial

— Matrix Neonat  

Official title:
Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03706651
Other study ID # TLM-MatrixNeonat
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date January 2018

Study information
Verified date September 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date January 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Less than 28 days of life

- Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Infants hospitalized in health facilities performing Tele-expertise

Locations
Country Name City State
France Service de radiopédiatrie Le Kremlin Bicêtre
France Service de radiopédiatrie - Hôpital Robert Debré Paris
France Service de radiopédiatrie. Hôpital Necker Paris
France Service de Radiopédiatrie. Hôpital Trousseau Paris

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Time between MRI and the specialist report 1 week after discharge
Secondary Time between MRI and the discussions with the parents 1 week after discharge
See also
  Status Clinical Trial Phase
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT00006516 - Home Stimulation for Brain-Asphyxiated Infants Phase 2
Completed NCT03268590 - Neuroimaging During Pure Oxygen Breathing Phase 4
Completed NCT04174417 - Effect of Hypotensive Anesthesia on Cerebral Perfusion and Blood Antioxidant Levels and HIF 1a N/A
Completed NCT03112486 - Out-of-hospital Cardiac Arrest (OHCA) Biomarkers
Completed NCT01793129 - Preemie Hypothermia for Neonatal Encephalopathy N/A
Completed NCT03100019 - Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans. N/A
Active, not recruiting NCT03145142 - PREMOD2 With Near Infrared Spectroscopy Sub-study N/A
Completed NCT04280744 - Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care N/A
Recruiting NCT05753345 - Aquatic Therapy for Children With Neuromotor Deficits N/A
Enrolling by invitation NCT04258774 - The Effect of Respiratory Challenge on the BOLD Signal N/A
Completed NCT03338907 - CO2 (Carbon Dioxide) - Cerebral Oxygenation Phase 2
Recruiting NCT01506258 - Autologous Stem Cells in Newborns With Oxygen Deprivation N/A
Not yet recruiting NCT03255408 - Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia Phase 1/Phase 2
Completed NCT04184245 - Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Recruiting NCT05564754 - Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation N/A
Recruiting NCT06207942 - Stepcare Extended Follow-up Substudy N/A
Completed NCT00614744 - Late Hypothermia for Hypoxic-Ischemic Encephalopathy N/A

External Links