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Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery

RecruitingNAAges 1 Day - 3 YearsAllYan Fuxia
NCT06861998 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ inj

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 0-3 years 2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass. 3. Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF). Exclusion Criteria: 1. Infants and toddlers who have taken any relevant preoperative treatment for sleep problems 2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4. 3. Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc. 4. Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations) 5. Concurrent participation in other clinical trials 6. Refusal of the family to sign the informed consent or poor compliance of the child.
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What it tests

  • Message-based bedtime routine
  • sleep hygiene education
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Where

1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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