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

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, 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.

Eligibility

Inclusion Criteria:

1. Age 0-36 months
2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)

Exclusion Criteria:

1. Preoperative use of sleep therapy-related medications
2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
4. Emergency surgery or preoperative ICU admission
5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression
6. Combined severe hepatic and renal dysfunction
7. 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)
8. History of preoperative cerebral ischemia and hypoxia
9. Concurrent participation in other clinical trials
10. Refusal of the family to sign the informed consent form or poor compliance by the child

Conditions4

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