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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease (CHD); Sleep Problems; Delirium - Postoperative
• Intervention / Treatment: Behavioral: Message-based bedtime routine; Behavioral: sleep hygiene education

Detailed Description

The study will be carried out in Fuwai Hospital, Chinese Academy of Medical Sciences, Anzhen Hospital Affiliated to Capital Medical University, Fuwai Central China Cardiovascular Hospital, Fuwai Cardiovascular Hospital of Yunnan Province, and Children's Hospital Affiliated to Capital Institute of Pediatrics.

The research process is as follows: Perform routine sleep disorder assessments on pediatric patients visiting the outpatient clinic. Fully inform the guardians of pediatric patients with sleep disorders of all the contents and procedures of this trial. After obtaining informed consent comprehensively and having the informed consent forms signed, conduct further assessments on the pediatric patients to determine whether they meet the inclusion and exclusion criteria. All enrolled children's guardians will receive sleep hygine education in the outpatient clinic. After stratification by research center, the random block is set to 4 - 6, the R will be used to randomly assign subjects to the experimental group and the control group at a 1:1 ratio. After randomization, the children in the experimental group receive behavioral interventions every day before surgery, specifically a bedtime routine based on massage/stroking. Guardians need to strictly implement it and cooperate with the researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). In the control group, parents are provided with sleep hygiene education for infants and toddlers, and no additional intervention measures are applied. To better control the quality of interventions for children aged 0 - 3 in the experimental group, the daily implementation status of parents is counted for the degree of implementation (0 - 100%) in the WeChat mini-program. Guardians record the children's daily sleep diaries (online questionnaires) before surgery. The day before surgery, they fill out the Brief Infant Sleep Questionnaire (BISQ) again and compare it with the baseline situation. After admission, children wear actigraphs until the day of surgery and until discharge after surgery to automatically record sleep-related information. After the children are enrolled in the study, relevant researchers will supervise the implementation of cognitive-behavioral interventions for the children once a day before surgery to ensure that the actigraph device functions properly during hospitalization and remind guardians to record electronic sleep diaries until the night before surgery. Follow-up will be conducted within 7 days after surgery or before discharge to evaluate outcomes such as delirium and pain. The primary outcome is the incidence of postoperative delirium, 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.

• Study Type: Interventional
• Enrollment (Estimated): 452
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuxia Yan; Phone Number: 010-88396628; Email: yanfuxia@sina.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital, Chinese Academy of Medical Sciences
    • Contact: Fuxia Yan; Phone Number: +861088396628; Email: yanfuxia@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 0-3 years
2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
3. Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).

Exclusion Criteria:

1. Infants and toddlers who have taken any relevant preoperative treatment for sleep problems
2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.
3. Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.
4. 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)
5. Concurrent participation in other clinical trials
6. Refusal of the family to sign the informed consent or poor compliance of the child.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Message-based bedtime routine; 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.	Behavioral: sleep hygiene education; Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of postoperative delirium	Postoperative 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale	The FLACC scale is a simple and effective tool used to assess pain in infants and non-verbal patients. It stands for Face, Legs, Activity, Cry, and Consolability. Each of these five items is scored on a scale of 0 to 2, with a higher score indicating a greater degree of pain. The total FLACC score, ranging from 0 to 10, provides a quick and reliable assessment of the patient's pain level.	Postoperative 7 days
The incidence of postoperative Liver dysfunction		Postoperative 7 days
Postoperative sleep quality	Postoperative sleep quality was assessed using the Actigraph model wGT3X-BT body movement recorder. The Actigraph model wGT3X-BT was worn from the time of admission to 7 days after surgery in order to assess the sleep quality of the subjects.	Postoperative 7 days or before discharge
The incidence of postoperative Acute kidney injury		Within postoperative 7 days
The incidence of Pulmonary complication		Postoperative 7 days
Concentration of intestinal fatty acid binding protein (I-FABP)	one of markers of intestinal injury	Before surgery, at the end of surgery and 24 hours after surgery
Concentration of zonulin	One of markers of intestinal injury	Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide (LPS)	One of markers of intestinal injury	Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide binding protein (LBP)	One of markers of intestinal injury	Before surgery, at the end of surgery and 24 hours after surgery
Types and dosages of drugs used for postoperative sedation and analgesia		Postoperative 7 days or before discharge
Levels of inflammatory cytokines	The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.	Before surgery, at the end of surgery and 24 hours after surgery
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR)	Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR) are two blood biomarkers based on blood cell counts, which reflect the inflammatory and immune status of the body; they were obtained based on preoperative and postoperative blood routine tests.	Before surgery, 24 hours after surgery
The duration of postoperative mechanical ventilation	The total hours needing mechanical ventilation support	From the end of the surgery to discharge from the hospital,up to 30 days
The length of intensive care unit stay	The time spent in the intensive care unit.	From the end of the surgery to discharge from the hospital,up to 30 days
The length of postoperative hospital stay		From the end of the surgery to the day of discharge from the hospital,up to 30 days
Average daily cost	total hospitalization cost divided by total length of stay	admission to discharge, up to 30days
Mechanistic endpoint: Concentration of plasma S-100β protein	S-100β protein was used as a surrogate biomarker for the disruption of the blood-brain barrier.	Before surgery, at the end of surgery and 24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Sleep quality score	guardians scored sleep quality 1-5 using a sleep diary	30 days, 6 months, 1 year after discharge
Readmission rate	the rate at which a patient is readmitted to the hospital for the same or a different health problem within 30 days/six months/1 year after discharge	30 days/6 months/1 year after discharge
1-Year Mortality and Survival	The rate at which patients die and survive within 1 year of discharge from the hospital.	1 year after discharge

Collaborators and Investigators

• Sponsor: Yan Fuxia
• Investigators: Principal Investigator: Fuxia Yan, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Sleep Wake Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Emergence Delirium; Delirium; Dyssomnias; Parasomnias; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2025-2603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No