Status:
RECRUITING
Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
Lead Sponsor:
Yan Fuxia
Conditions:
Delirium - Postoperative
Sleep Problems
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
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,...
Detailed Description
The study will be carried out in Fuwai Hospital, Chinese Academy of Medical Sciences, Anzhen Hospital Affiliated to Capital Medical University, Fuwai Central China Cardiovascular Hospital, Fuwai Cardi...
Eligibility Criteria
Inclusion
- Age 0-36 months
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
- Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)
Exclusion
- Preoperative use of sleep therapy-related medications
- The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
- History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
- Emergency surgery or preoperative ICU admission
- History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression
- Combined severe hepatic and renal dysfunction
- Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders)
- History of preoperative cerebral ischemia and hypoxia
- Concurrent participation in other clinical trials
- Refusal of the family to sign the informed consent form or poor compliance by the child
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT06879431
Start Date
April 28 2025
End Date
December 31 2026
Last Update
May 31 2025
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100037