Cerebral Disorders CongenitalNCT04775641
Italian Survey on Paediatric and Neonatal MRI
An observational study of Cerebral Disorders Congenital and Premature Birth, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Cerebral Disorders Congenital, Premature Birth
- What is being tested?
- questionnaire
- How many people
- 876 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Sep 2019
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: All center perforing a paediatric discharge in Italy in the 2014
Who may be able to join
- Uncooperative children < 14 years old
- premature babies
Who cannot join
- . collaborating children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Children and Neonates Anaesthesia in Magnetic Resonance Environment in Italy. An Active Call Survey
Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. In this active call survey, the authors sought to delineate the Italian situation regarding national centers, staff involved, monitoring and tools available. The primary aim was to evaluate clinical practice in childhood management in Magnetic Resonance suite.
This study was designed as prospective phone survey on the setting of a complete sample of all national centers performing almost a paediatric discharge in the 2014, obtained from Italian Health Ministery registers.
The three section survey was fill out with the Physician in charge in Magnetic Resonance suite. The Main outcome was a descriptive and exploratory analyses about the organization setting of the Centers (procedures, performers, monitoring and tools).
- Conditions
- Cerebral Disorders Congenital, Premature Birth
- Being tested
- questionnaire
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive practice for children and neonates management in MRI
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2019
- Primary completion15 Feb 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Disorders CongenitalStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SPINAZZOLA GIORGIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775641
- Sponsor's protocol ID
- MRI001
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sbaraglia F, Spinazzola G, Adduci A, Continolo N, De Riso M, Ferrone G, Festa R, Garra R, Tosi F, Rossi M. Children and neonates anesthesia in magnetic resonance environment in Italy: an active call survey. BMC Anesthesiol. 2022 Sep 2;22(1):279. doi: 10.1186/s12871-022-01821-3.
PubMed 36056321
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Neonates Anaesthesia in Magnetic Resonance Environment in Italy. An Active Call Survey
- ClinicalTrials.gov ID
- NCT04775641
- Acronym / sponsor ID
- MRI001
- Conditions
- Cerebral Disorders Congenital, Premature Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Mar 2021 (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.
Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. In this active call survey, the authors sought to delineate the Italian situation regarding national centers, staff involved, monitoring and tools available. The primary aim was to evaluate clinical practice in childhood management in Magnetic Resonance suite.
This study was designed as prospective phone survey on the setting of a complete sample of all national centers performing almost a paediatric discharge in the 2014, obtained from Italian Health Ministery registers.
The three section survey was fill out with the Physician in charge in Magnetic Resonance suite. The Main outcome was a descriptive and exploratory analyses about the organization setting of the Centers (procedures, performers, monitoring and tools).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All center perforing a paediatric discharge in Italy in the 2014
Key inclusion criteria (2 listed)
- Uncooperative children < 14 years old
- premature babies
Key exclusion criteria (1 listed)
- . collaborating children
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 |
|---|---|---|
| questionnairequestionnaire | Other | – |
Primary outcome
Descriptive practice for children and neonates management in MRI
Time frame: 3 monthes
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 6 Oct 2021.
- Derived from this study: PubMed 36056321Sbaraglia F, Spinazzola G, Adduci A, Continolo N, De Riso M, Ferrone G, Festa R, Garra R, Tosi F, Rossi M. Children and neonates anesthesia in magnetic resonance environment in Italy: an active call survey. BMC Anesthesiol. 2022 Sep 2;22(1):279. doi: 10.1186/s12871-022-01821-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Disorders Congenital and Premature Birth, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Descriptive practice for children and neonates management in MRI (time frame: 3 monthes). 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 NCT04775641, which also lists 1 linked publication.
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 6 Oct 2021.