Lateral Position MRI in Preterm Infants, an Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Prematurity Magnetic Field Exposure Sedation Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

50 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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fabio sbaraglia

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli IRCCS

Locations

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Policlinico Univeristario Agostino Gemelli

Roma, Rome, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED

PMID: 39696670 (View on PubMed)

Other Identifiers

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5259B

Identifier Type: -

Identifier Source: org_study_id