Lateral Position MRI in Preterm Infants, an Observational Study

Prematurity Clinical Trial

— MRIOPS  

Official title:

Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05776238
• Other study ID #: 5259B
• Status: Completed
• Start date: February 16, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 50 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Field Exposure
• Premature Birth
• Prematurity
• Sedation Complication

Locations

Country	Name	City	State
Italy	Policlinico Univeristario Agostino Gemelli	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral oxygen desaturation	Number of episodes of peripheral oxygen desaturation < 90% during deep sedation	Through study completion, an average of 7 month
Primary	Apnea	Number of episodes of apnea > 20 sec during deep sedation	Through study completion, an average of 7 month
Secondary	Subjective evaluation of imaging quality	Subjective evaluation of images by two neuroradiologists measured as Score (1-5 points) in 5 categories	Through study completion, an average of 7 month
Secondary	Objective evaluation of imaging quality	Objective evaluation of image quality by measuring the Signal to Noise Ratio (SNR)	Through study completion, an average of 7 month
Secondary	Post-operative temperature control	Measurement of rectal core body temperature (°C) after the exam	Through study completion, an average of 7 month
Secondary	Time for full enteral feeding	How many hours for full enteral feeding after the preoperative fasting	Through study completion, an average of 7 month
Secondary	Objective evaluation of imaging quality	Objective evaluation of image quality by measuring the Contrast to Noise Ratio (CNR)	Through study completion, an average of 7 month