Actively Recruiting
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Led by Yan Fuxia · Updated on 2025-05-28
452
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
CONDITIONS
Official Title
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0-3 years
- Scheduled for elective corrective surgery for congenital heart disease with cardiopulmonary bypass
- Sleep disorders identified by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF)
You will not qualify if you...
- Received any preoperative treatment for sleep problems
- Risk adjustment in congenital heart surgery-1 (RACHS-1) classification 4 or higher
- History of cerebral ischemia, hypoxia, or developmental disorders such as autism spectrum disorder
- Presence of acute or chronic medical conditions including mechanical ventilation, asphyxia rescue, severe liver or kidney dysfunction, or other non-cardiac malformations
- Participation in other clinical trials
- Family refusal to sign informed consent or poor compliance of the child
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100037
Actively Recruiting
Research Team
F
Fuxia Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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