Clinical trial NCT06861998: Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Official title: The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers 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: 2025-03-06
Enrollment: 452
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
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 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.

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.

Eligibility criteria: 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.

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: Postoperative sleep quality
timeFrame: Postoperative 7 days or before discharge
measure: Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
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: Levels of inflammatory cytokines
timeFrame: Before surgery, at the end of surgery and 24 hours after surgery
measure: Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR)
timeFrame: Before surgery, 24 hours after surgery
measure: The duration of postoperative mechanical ventilation
timeFrame: From the end of the surgery to discharge from the hospital,up to 30 days
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, 6 months, 1 year after discharge
measure: Readmission rate
timeFrame: 30 days/6 months/1 year after discharge
measure: 1-Year Mortality and Survival
timeFrame: 1 year after discharge
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: