The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 3
Healthy Volunteers: f
View:

• Age 0-3 years

• Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

• Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).

Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Fuxia Yan
yanfuxia@sina.com
010-88396628
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 452
Treatments
Experimental: Message-based bedtime routine group
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
Other: Sleep hygiene education group
The control group received only sleep hygiene education.
Related Therapeutic Areas
Sponsors
Leads: Yan Fuxia

This content was sourced from clinicaltrials.gov