Clinical Trial

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

Recruiting
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Record status
This record was last updated May 31, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-14; most recent amendment 2025-05-27.
Status change: Not Yet Recruiting → Recruiting 2025-05-27
Trial Details
NCT Number NCT06879431
Lead Sponsor Yan Fuxia
Conditions Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
Enrollment 544 participants
Start Date 2025-04-28
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-31