Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

Recruiting now · Not applicable

Conditions studied: Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)

In brief

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.

Key facts

Study ID

NCT06879431

Run by

Yan Fuxia

People needed

544

Starts

2025-04-28

Expected to finish

2026-12-31

Last updated by the study team

2025-05-31

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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