Lateral Position MRI in Preterm Infants, an Observational Study

Completed

• Conditions: Prematurity; Sedation Complication; Magnetic Field Exposure

• Registration Number: NCT05776238
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-16
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• < 40 weeks Post Conceptional Age (PCA)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral oxygen desaturation	Through study completion, an average of 7 month	Number of episodes of peripheral oxygen desaturation \< 90% during deep sedation
Apnea	Through study completion, an average of 7 month	Number of episodes of apnea \> 20 sec during deep sedation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico Univeristario Agostino Gemelli; 🇮🇹 Roma, Rome, Italy