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

NCT06861998 | Recruiting

• 1 other identifier: 2025-2603
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  Postoperative 7 days

Secondary Outcomes (17)

• Mechanistic endpoint: Concentration of plasma S-100β protein

  Before surgery, at the end of surgery and 24 hours after surgery

• Postoperative sleep quality

  Postoperative 7 days or before discharge

• Pain defined by the Face, Legs, Activity, Cry, and Consolability scale

  Postoperative 7 days

• The incidence of postoperative Acute kidney injury

  Within postoperative 7 days

• The incidence of Pulmonary complication

  Postoperative 7 days

Other Outcomes (3)

• Long-term Sleep quality score

  30 days, 6 months, 1 year after discharge

• Readmission rate

  30 days/6 months/1 year after discharge

• 1-Year Mortality and Survival

  1 year after discharge

Study Arms (2)

Message-based bedtime routine group

EXPERIMENTAL

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

Behavioral: Message-based bedtime routine

Sleep hygiene education group

OTHER

The control group received only sleep hygiene education.

Behavioral: sleep hygiene education

Interventions

Message-based bedtime routine BEHAVIORAL

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

Message-based bedtime routine group

sleep hygiene education BEHAVIORAL

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

Sleep hygiene education group

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Infants and toddlers who have taken any relevant preoperative treatment for sleep problems
• The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.
• Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.
• Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations)
• Concurrent participation in other clinical trials
• Refusal of the family to sign the informed consent or poor compliance of the child.

Sponsors & Collaborators

• Yan Fuxia: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Parasomnias; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fuxia Yan

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuxia Yan

CONTACT

010-88396628; yanfuxia@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)