Clinical Trial: Evaluation of the Usefulness of Short-Duration Brain MRI for Detecting Intracranial Lesions During the Perioperative Period of Neonatal and Early-Infant Open-Heart Surgery (Japan)

Tokyo, Nov. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059688) titled 'ORION Study: Open-heart perioperative Rapid MRI Of Neonates/infants' on Nov. 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Miyagi Children's Hospital

Condition: Condition - Congenital heart disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluation of the Diagnostic Performance and Clinical Usefulness of Short-Duration Brain MRI in Detecting Intracranial Lesions During the Perioperative Period of Neonatal Open-Heart Surgery with Cardiopulmonary Bypass Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Sedation for Short-duration brain MRI protocol

Eligibility: Age-lower limit - 1 days-old = Gender - Male and Female Key inclusion criteria - Neonates and infants eligible for brain MRI during the perioperative period of open-heart surgery performed at our institution between October 20, 2025, and March 31, 2027. Key exclusion criteria - Patients in whom sedation for brain MRI is considered difficult. Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 30 Day Date of IRB - 2025 Year 09 Month 30 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067629

Disclaimer: Curated by HT Syndication.