About this trial
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.
Eligibility criteria
Qualifiers
Age 0-36 months
Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score >48)
Disqualifiers
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
Trial design
Treatments tested in this trial
- cognitive-behavioral intervention
Treatment groups
Sponsors and collaborators
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution