Clinical trial NCT06879431: Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
Official title: The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium - Postoperative
Sleep Problems
Congenital Heart Disease (CHD)
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 544
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: Conduct a routine assessment of sleep disorders for the children visiting the outpatient clinic. The guardians fill out the online Children's Sleep Habits Questionnaire. Fully inform the children with sleep disorders and their guardians of all the contents and procedures of this trial. After obtaining informed consent and signing the informed consent form, conduct a further assessment on the children to determine whether they meet the inclusion and exclusion criteria. All enrolled children and their guardians will receive preoperative education for congenital heart disease 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 parents of children in the experimental group register for a WeChat mini-program, and the children receive cognitive-behavioral interventions every day before surgery. Guardians need to strictly implement and cooperate with researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). The control group does not receive any intervention and follows routine clinical practice. To better control the quality of interventions for children aged 6 - 12 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, parents fill out the online Children's Sleep Habits Questionnaire again and compare the scores with the baseline scores. 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.

Eligibility criteria: Inclusion Criteria:

1. Age 0-36 months
2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)

Exclusion Criteria:

1. Preoperative use of sleep therapy-related medications
2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
4. Emergency surgery or preoperative ICU admission
5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression
6. Combined severe hepatic and renal dysfunction
7. 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)
8. History of preoperative cerebral ischemia and hypoxia
9. Concurrent participation in other clinical trials
10. Refusal of the family to sign the informed consent form or poor compliance by the child

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Mechanistic endpoint: Concentration of plasma S-100β protein
timeFrame: Before surgery, at the end of surgery and 24 hours after surgery
measure: Pain defined by the Wong-Baker faces pain scale (revision)
timeFrame: Postoperative 7 days
measure: The incidence of postoperative Acute kidney injury
timeFrame: Within postoperative 7 days
measure: The incidence of Pulmonary complication
timeFrame: Postoperative 7 days
measure: The incidence of postoperative Liver dysfunction
timeFrame: Postoperative 7 days
measure: Concentration of intestinal fatty acid binding protein (I-FABP)
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of zonulin
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of lipopolysaccharide (LPS)
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of lipopolysaccharide binding protein (LBP)
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Types and dosages of drugs used for postoperative sedation and analgesia
timeFrame: Postoperative 7 days or before discharge
measure: Concentration of IL-6
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of TNF-α
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of IL-1β
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of IFN-γ
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of IL-17
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: Concentration of C-reactive protein
timeFrame: before surgery, at the end of surgery and 24 hours after surgery
measure: The duration of postoperative mechanical ventilation
timeFrame: From the end of the surgery to the removal of the tracheal intubation，up to 30days
measure: The length of intensive care unit stay
timeFrame: From the end of the surgery to discharge from the hospital,up to 30 days
measure: The length of postoperative hospital stay
timeFrame: From the end of the surgery to the day of discharge from the hospital,up to 30 days
measure: Average daily cost
timeFrame: admission to discharge, up to 30days
Other outcomes:
measure: Long-term Sleep quality score
timeFrame: 30 days, six months, 1 year postoperatively
measure: Strengths and Difficulties Questionnaire Score
timeFrame: 6 months and 1 year after surgery
measure: Readmission rate
timeFrame: 30 days,6 months,1 year after discharge
measure: 1-year mortality
timeFrame: 1 year after surgery
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Fuxia Yan
role: PRINCIPAL_INVESTIGATOR
References: