Actively Recruiting
Impact of Behavioral Intervention on Postoperative Delirium in Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter Randomized Controlled Trial
Led by Yan Fuxia · Updated on 2025-05-28
452
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying infants and toddlers with sleep disorders who are undergoing elective congenital heart surgery to see if preoperative sleep interventions can reduce negative outcomes like postoperative delirium. This randomized controlled trial compares sleep hygiene education alone to sleep hygiene education combined with a bedtime routine involving massage. The study aims to provide insights for preventing delirium after heart surgery in young children. Participants will be randomly assigned to one of two groups: an intervention group receiving sleep hygiene education plus a massage-based bedtime routine, and a control group receiving only sleep hygiene education. The intervention involves daily behavioral routines carried out before surgery, with guardians supported through phone or face-to-face contacts and tracking via a WeChat mini-program. Sleep diaries and actigraph devices will be used to monitor sleep before and after surgery. During the study, guardians will complete sleep questionnaires and record sleep patterns, while children will wear actigraphs to track sleep automatically. Researchers will supervise intervention adherence daily until surgery. After surgery, participants will be monitored for seven days or until discharge for outcomes including delirium incidence, sleep quality, pain, organ injury, and recovery. Various blood markers and clinical data will also be collected to assess effects and prognosis.
CONDITIONS
Brief Title
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 3 years
- Scheduled for elective corrective surgery for congenital heart disease with cardiopulmonary bypass
- Diagnosed with sleep disorder by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF)
You will not qualify if you...
- Received any preoperative treatment for sleep problems
- High surgical risk classified as RACHS-1 score 4 or above
- History of cerebral ischemia, hypoxia, or developmental disorders such as autism
- Presence of acute or chronic medical conditions like mechanical ventilation, severe liver or kidney dysfunction, or other non-cardiac malformations
- Participation in other clinical trials
- Family refusal to sign informed consent or poor compliance by child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (outpatient clinic)
Duration - From enrollment until the day before surgery
Participants receive sleep hygiene education and complete baseline sleep disorder assessments. Guardians record children's daily sleep diaries and participate in behavioral interventions or education depending on group assignment.
Daily remote or face-to-face interactions before surgery
Duration - Day of surgery up to hospital discharge
Participants undergo elective corrective congenital heart surgery with cardiopulmonary bypass. Actigraphs are worn continuously from admission until discharge to monitor sleep.
Hospital admission and surgery day visits plus continuous monitoring
Duration - Up to 7 days post-surgery or until discharge
Participants are followed up for up to 7 days after surgery or until discharge to evaluate postoperative delirium, pain, sleep quality, organ function, and recovery.
Daily assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100037
Actively Recruiting
Research Team
F
Fuxia Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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