Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06861998
NA

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

Sponsor: Yan Fuxia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Day - 3 Years

Study Type

INTERVENTIONAL

Enrollment

452

Start Date

2025-04-30

Completion Date

2026-12-31

Last Updated

2025-05-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

Message-based bedtime routine

The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.

BEHAVIORAL

sleep hygiene education

Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China