Pre-surgery sleep program to reduce delirium after congenital heart surgery in infants and toddlers
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
This study will try a short cognitive-behavioral sleep program before elective congenital heart surgery to see if it lowers postoperative delirium in infants and toddlers (0–36 months) with sleep problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 544 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06879431 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized controlled trial enrolling children aged 0–36 months with sleep disorders (CSHQ score >48) who are scheduled for elective corrective congenital heart surgery under cardiopulmonary bypass. After screening and consent, participants are randomized 1:1 by center to receive either a brief intensive preoperative cognitive-behavioral sleep intervention delivered daily 7–14 days before surgery via a WeChat mini-program with parent support, or usual care with no added sleep intervention. The primary outcome is the incidence of postoperative delirium and other adverse postoperative outcomes. The trial is conducted at several major cardiac and pediatric centers in China, with standardized assessments and follow-up around the surgical episode.
Who should consider this trial
Good fit: Infants and toddlers (0–36 months) with congenital heart defects scheduled for elective corrective surgery under cardiopulmonary bypass who have sleep problems (CSHQ score >48) and meet other inclusion/exclusion criteria are ideal candidates.
Not a fit: Children requiring emergency surgery, with high surgical risk (RACHS-1 ≥4), preexisting neurodevelopmental or psychiatric disorders, severe organ dysfunction, or current sleep medication use are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could reduce postoperative delirium and improve recovery after congenital heart surgery for affected infants and toddlers.
How similar studies have performed: Behavioral sleep therapies have shown benefit for pediatric sleep problems, but using a brief preoperative cognitive-behavioral program specifically to prevent postoperative delirium in infants with CHD is largely novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fuxia Yan — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Fuxia Yan
- Email: yanfuxia@sina.com
- Phone: 010 88396628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.