Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery

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 infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

NCT Number	NCT06861998
Lead Sponsor	Yan Fuxia
Conditions	Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
Enrollment	452 participants
Start Date	2025-04-30
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-28