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

NCT06861998 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Delirium - Postoperative
  • Sleep Problems
  • Congenital Heart Disease (CHD)

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.

Sponsors & Collaborators

  • Yan Fuxia

    lead OTHER

Principal Investigators

  • Fuxia Yan · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861998 on ClinicalTrials.gov