Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Cong… (NCT06879431) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
China544 participantsStarted 2025-04-28
Plain-language 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.
Who can participate
Age range6 Years – 12 Years
SexALL
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Inclusion criteria
✓. Age 0-36 months
✓. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
✕. 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