Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

NCT06879431 | Recruiting

• 1 other identifier: 2025-2602
• Study Type: interventional
• Target: 544
• 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  Postoperative 7 days

Secondary Outcomes (20)

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

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

• Pain defined by the Wong-Baker faces pain scale (revision)

  Postoperative 7 days

• The incidence of postoperative Acute kidney injury

  Within postoperative 7 days

• The incidence of Pulmonary complication

  Postoperative 7 days

• The incidence of postoperative Liver dysfunction

  Postoperative 7 days

Other Outcomes (4)

• Long-term Sleep quality score

  30 days, six months, 1 year postoperatively

• Strengths and Difficulties Questionnaire Score

  6 months and 1 year after surgery

• Readmission rate

  30 days,6 months,1 year after discharge

Study Arms (2)

CBT group

EXPERIMENTAL

The intervention group received a short intensive cognitive-behavioral therapy (CBT) intervention 7-14 days before surgery

Behavioral: cognitive-behavioral intervention

control group

NO INTERVENTION

no intervention was imposed on the control group

Interventions

cognitive-behavioral intervention BEHAVIORAL

After enrollment in the experimental group, the guardians were asked to fill out a sleep diary every day before surgery to self-report the children's sleep, and to wear a somatic movement recorder to monitor sleep (non-dominant arm) (wGT3x-BT accelerometer, ActiGraph) during the preoperative hospitalization period, except during surgery, and then to wear it to record the sleep-related parameters until 7 days after surgery or before discharge from the hospital.Preoperative daily cognitive-behavioral interventions (developmental trials were guided with WeChat applets), including cognitive change, sleep hygiene, sleep restriction, stimulus control, and relaxation training

CBT group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression
• Combined severe hepatic and renal dysfunction
• Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders)
• History of preoperative cerebral ischemia and hypoxia
• Concurrent participation in other clinical trials
• Refusal of the family to sign the informed consent form or poor compliance by 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 17, 2025
• Study Start: April 28, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)