Clinical Trial

Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery

Not Yet Recruiting
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Record status
This record was last updated November 13, 2024 (before its estimated November 10, 2025 completion). Its status may not reflect the trial's current state.
Summary
The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.
Trial Details
NCT Number NCT06686550
Lead Sponsor Yan Fuxia
Conditions Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
Enrollment 435 participants
Start Date 2024-11-10
Primary Completion 2025-11-10 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2024-11-13