Lateral Position MRI in Preterm Infants, an Observational Study (MRIOPS)

December 21, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy
        • Policlinico Univeristario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 11 months (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prematures babies during in hospital stay

Description

Inclusion Criteria:

  • < 40 weeks Post Conceptional Age (PCA)

Exclusion Criteria:

  • > 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral oxygen desaturation
Time Frame: Through study completion, an average of 7 month
Number of episodes of peripheral oxygen desaturation < 90% during deep sedation
Through study completion, an average of 7 month
Apnea
Time Frame: Through study completion, an average of 7 month
Number of episodes of apnea > 20 sec during deep sedation
Through study completion, an average of 7 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective evaluation of imaging quality
Time Frame: Through study completion, an average of 7 month
Subjective evaluation of images by two neuroradiologists measured as Score (1-5 points) in 5 categories
Through study completion, an average of 7 month
Objective evaluation of imaging quality
Time Frame: Through study completion, an average of 7 month
Objective evaluation of image quality by measuring the Signal to Noise Ratio (SNR)
Through study completion, an average of 7 month
Post-operative temperature control
Time Frame: Through study completion, an average of 7 month
Measurement of rectal core body temperature (°C) after the exam
Through study completion, an average of 7 month
Time for full enteral feeding
Time Frame: Through study completion, an average of 7 month
How many hours for full enteral feeding after the preoperative fasting
Through study completion, an average of 7 month
Objective evaluation of imaging quality
Time Frame: Through study completion, an average of 7 month
Objective evaluation of image quality by measuring the Contrast to Noise Ratio (CNR)
Through study completion, an average of 7 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: fabio sbaraglia, Fondazione Policlinico Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5259B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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