Hypoxia, BrainMatrix NeonatNCT03706651
Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
An observational study of Hypoxia, Brain, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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 Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Hypoxia, Brain
- What is being tested?
- Infants hospitalized in health facilities performing Tele-expertise
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2014to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants hospitalized in neonatology unit
Who may be able to join
- Less than 28 days of life
- Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de radiopédiatrie
Le Kremlin-Bicêtre, 94275
Service de Radiopédiatrie. Hôpital Trousseau
Paris, 75012
Service de radiopédiatrie. Hôpital Necker
Paris, 75015
Service de radiopédiatrie - Hôpital Robert Debré
Paris, 75019
About this study
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
- Conditions
- Hypoxia, Brain
- Being tested
- Infants hospitalized in health facilities performing Tele-expertise
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants hospitalized in health facilities performing Tele-expertiseDevice
| Study group | Role | What they receive |
|---|---|---|
| Exposed group, during Tele-expertise | Infants hospitalized in health facilities performing tele-expertise Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after discharge
Secondary outcomes (2)
Time between MRI and the specialist report
Measured: 1 week after discharge
Time between MRI and the discussions with the parents
Measured: 1 week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startJan 2014
- Primary completionOct 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxia, BrainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Elisabeth Dion, MD, PhD, Principal investigator, Centre de téléradiologie, Assistance Publique, Hôpitaux de ParisIsabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706651
- Sponsor's protocol ID
- TLM-MatrixNeonat
- Acronym
- Matrix Neonat
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18328928Kidholm 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.
PubMed 22617736
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae
- ClinicalTrials.gov ID
- NCT03706651
- Acronym / sponsor ID
- Matrix Neonat / TLM-MatrixNeonat
- Conditions
- Hypoxia, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Jan 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group, during Tele-expertise | – | Device: Infants hospitalized in health facilities performing Tele-expertiseInfants 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 |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants hospitalized in neonatology unit
Key inclusion criteria (2 listed)
- Less than 28 days of life
- Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infants hospitalized in health facilities performing Tele-expertise | Device | Exposed group, during Tele-expertise |
Primary outcome
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.
2 secondary outcomes
Time between MRI and the specialist report
Time frame: 1 week after discharge
Time between MRI and the discussions with the parents
Time frame: 1 week after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 18328928Larroque 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.
- Background: PubMed 22617736Kidholm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Dion, MD, PhD principal investigator
Centre de téléradiologie, Assistance Publique, Hôpitaux de Paris
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, Brain, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between MRI and decision of intensive care continuation (time frame: 1 week after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706651, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.