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Study identifier: NCT06861998 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Delirium - Postoperative · Sleep Problems · Congenital Heart Disease (CHD)  ·  Sponsor: Yan Fuxia

PhaseNA
Planned participants452
Who can joinAll sexes, 1 Day to 3 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Fuxia Yan  ·  010-88396628  ·  yanfuxia@sina.com

Always discuss trial participation with your own doctor first.

Locations (1)

Fuwai Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06861998