PrematurityMRIOPSNCT05776238
Lateral Position MRI in Preterm Infants, an Observational Study
An observational study of Prematurity and Magnetic Field Exposure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are: number of apneas during sedation Maintenance of eupnea during deep sedation Read more about this study
- Who is it for?
- Ages Up to 50 weeks
- Conditions the study is for
- Prematurity, Magnetic Field Exposure, Sedation Complication
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2023to 30 Sep 2023
- 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 50 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Prematures babies during in hospital stay
Who may be able to join
- < 40 weeks Post Conceptional Age (PCA)
Who cannot join
- > 50 weeks PCA
- previous treatment with hypothermia for neonatal asphyxia
- patients who received invasive positive pressure ventilation within the previous 48 h
- preexisting cardiac arrhythmias
- presence or suspicion of oncological pathology
- neuromuscular or metabolic diseases
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- previous brain or abdominal surgery
- presence of epicranial venous accesses
- upper respiratory tract infections
- refusal of informed consent by parents or inability to express it
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study
The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are:
- number of apneas during sedation
- Maintenance of eupnea during deep sedation
Read the detailed description
Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.
- Conditions
- Prematurity, Magnetic Field Exposure, Sedation Complication
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral oxygen desaturation
Number of episodes of peripheral oxygen desaturation < 90% during deep sedation
Measured: Through study completion, an average of 7 month
Apnea
Number of episodes of apnea > 20 sec during deep sedation
Measured: Through study completion, an average of 7 month
Secondary outcomes (5)
Subjective evaluation of imaging quality
Subjective evaluation of images by two neuroradiologists measured as Score (1-5 points) in 5 categories
Measured: Through study completion, an average of 7 month
Objective evaluation of imaging quality
Objective evaluation of image quality by measuring the Signal to Noise Ratio (SNR)
Measured: Through study completion, an average of 7 month
Post-operative temperature control
Measurement of rectal core body temperature (°C) after the exam
Measured: Through study completion, an average of 7 month
Time for full enteral feeding
How many hours for full enteral feeding after the preoperative fasting
Measured: Through study completion, an average of 7 month
Objective evaluation of imaging quality
Objective evaluation of image quality by measuring the Contrast to Noise Ratio (CNR)
Measured: Through study completion, an average of 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start16 Feb 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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 PrematurityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fabio sbaraglia, Principal investigator, Fondazione Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776238
- Sponsor's protocol ID
- 5259B
- Acronym
- MRIOPS
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sbaraglia F, Gaudino S, Tiberi E, Maiellare F, Spinazzola G, Garra R, Della Sala F, Micci DM, Russo R, Riitano F, Ferrara G, Vento G, Rossi M. Deep sedation in lateral position for preterm infants during cerebral magnetic resonance imaging: a pilot study. J Anesth Analg Crit Care. 2024 Dec 18;4(1):80. doi: 10.1186/s44158-024-00216-9.
PubMed 39696670
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study
- ClinicalTrials.gov ID
- NCT05776238
- Acronym / sponsor ID
- MRIOPS / 5259B
- Conditions
- Prematurity, Magnetic Field Exposure, Sedation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Mar 2023 (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 goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are:
- number of apneas during sedation
- Maintenance of eupnea during deep sedation
Detailed description
Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 50 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prematures babies during in hospital stay
Key inclusion criteria (1 listed)
- < 40 weeks Post Conceptional Age (PCA)
Key exclusion criteria (10 listed)
- > 50 weeks PCA
- previous treatment with hypothermia for neonatal asphyxia
- patients who received invasive positive pressure ventilation within the previous 48 h
- preexisting cardiac arrhythmias
- presence or suspicion of oncological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral oxygen desaturation
Time frame: Through study completion, an average of 7 month
Number of episodes of peripheral oxygen desaturation < 90% during deep sedation
Apnea
Time frame: Through study completion, an average of 7 month
Number of episodes of apnea > 20 sec during deep sedation
5 secondary outcomes
Subjective evaluation of imaging quality
Time frame: Through study completion, an average of 7 month
Objective evaluation of imaging quality
Time frame: Through study completion, an average of 7 month
Post-operative temperature control
Time frame: Through study completion, an average of 7 month
Time for full enteral feeding
Time frame: Through study completion, an average of 7 month
Objective evaluation of imaging quality
Time frame: Through study completion, an average of 7 month
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 22 Dec 2023.
- Derived from this study: PubMed 39696670Sbaraglia F, Gaudino S, Tiberi E, Maiellare F, Spinazzola G, Garra R, Della Sala F, Micci DM, Russo R, Riitano F, Ferrara G, Vento G, Rossi M. Deep sedation in lateral position for preterm infants during cerebral magnetic resonance imaging: a pilot study. J Anesth Analg Crit Care. 2024 Dec 18;4(1):80. doi: 10.1186/s44158-024-00216-9.
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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.
fabio sbaraglia principal investigator
Fondazione Policlinico Gemelli IRCCS
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 Prematurity and Magnetic Field Exposure, 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 1 inclusion and 10 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 22 Dec 2023. 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?
Peripheral oxygen desaturation (time frame: Through study completion, an average of 7 month). The study lists 2 primary outcomes in all. 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 NCT05776238, 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 22 Dec 2023.