Actively Recruiting
Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
Led by Yan Fuxia · Updated on 2025-05-31
544
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 school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. 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 School-aged Children Undergoing Congenital Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 36 months
- Scheduled for elective corrective surgery for congenital heart disease using cardiopulmonary bypass
- Diagnosed with sleep disorder by Children's Sleep Habits Questionnaire with score greater than 48
You will not qualify if you...
- Use of sleep therapy medications before surgery
- Risk Adjustment in Congenital Heart Surgery-1 (RACHS-1) score 4 or higher
- History of preoperative cardiac assist device, mechanical ventilation, or asphyxia rescue
- Emergency surgery or preoperative ICU admission
- History of neurodevelopmental or psychiatric disorders such as autism, ADHD, or depression
- Severe liver or kidney dysfunction
- Presence of non-cardiac malformations like adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeorge syndrome, diabetes mellitus, reproductive abnormalities, anal atresia, Williams syndrome, or eye disorders
- History of preoperative brain ischemia or hypoxia
- Participation in other clinical trials
- Family refusal to sign consent or poor compliance by 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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