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OpenTrials
Completed

NCT Number: NCT05776238

Lateral Position MRI in Preterm Infants, 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

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Magnetic Field Exposure Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Sedation Complication Urogenital Diseases

Age range

Up to 50 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Univeristario Agostino Gemelli

Roma, Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Peripheral oxygen desaturation

    Time frame: Through study completion, an average of 7 month

    Number of episodes of peripheral oxygen desaturation < 90% during deep sedation

  2. Apnea

    Time frame: Through study completion, an average of 7 month

    Number of episodes of apnea > 20 sec during deep sedation

Secondary outcomes

  1. 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

  2. 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)

  3. Post-operative temperature control

    Time frame: Through study completion, an average of 7 month

    Measurement of rectal core body temperature (°C) after the exam

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: MRIOPS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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