Lateral Position MRI in Preterm Infants, an Observational Study
MRIOPS
Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study
1 other identifier
observational
22
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2023
CompletedFirst Submitted
Initial submission to the registry
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedDecember 22, 2023
February 1, 2023
8 months
February 17, 2023
December 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Peripheral oxygen desaturation
Number of episodes of peripheral oxygen desaturation \< 90% during deep sedation
Through study completion, an average of 7 month
Apnea
Number of episodes of apnea \> 20 sec during deep sedation
Through study completion, an average of 7 month
Secondary Outcomes (5)
Subjective evaluation of imaging quality
Through study completion, an average of 7 month
Objective evaluation of imaging quality
Through study completion, an average of 7 month
Post-operative temperature control
Through study completion, an average of 7 month
Time for full enteral feeding
Through study completion, an average of 7 month
Objective evaluation of imaging quality
Through study completion, an average of 7 month
Eligibility Criteria
Prematures babies during in hospital stay
You may qualify if:
- \< 40 weeks Post Conceptional Age (PCA)
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Univeristario Agostino Gemelli
Roma, Rome, Italy
Related Publications (1)
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.
PMID: 39696670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
fabio sbaraglia
Fondazione Policlinico Gemelli IRCCS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2023
First Posted
March 20, 2023
Study Start
February 16, 2023
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
December 22, 2023
Record last verified: 2023-02