Lateral Position MRI in Preterm Infants, an Observational Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05776238

Acronym

MRIOPS

Enrollment

Registered

2023-03-20

Start date

2023-02-16

Completion date

2023-09-30

Last updated

2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Field Exposure, Prematurity, Sedation Complication

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 50 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Signal to Noise Ratio (SNR)
Time for full enteral feeding	Through study completion, an average of 7 month	How many hours for full enteral feeding after the preoperative fasting

Countries

Italy

Outcome results