Improving sleep before heart surgery to reduce delirium in young children
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 study is testing if a special bedtime routine can help young children sleep better before heart surgery and reduce the chances of them experiencing confusion afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 1 Day to 3 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06861998 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled clinical trial investigates whether preoperative sleep interventions can decrease the incidence of postoperative delirium in infants and toddlers with sleep disorders undergoing congenital heart surgery. Participants will be randomly assigned to either an intervention group, which receives a massage-based bedtime routine along with sleep hygiene education, or a control group that only receives sleep hygiene education. The primary outcome measured will be the occurrence of postoperative delirium within 7 days after surgery, while secondary outcomes will include sleep quality, pain scores, and other clinical recovery metrics. The study aims to provide evidence on the effectiveness of sleep interventions in improving postoperative outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and toddlers aged 0-3 years scheduled for elective corrective surgery for congenital heart disease and diagnosed with sleep disorders.
Not a fit: Patients who have severe congenital heart conditions classified as RACHS-1 ≥4 or those with significant preoperative medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of postoperative delirium in young children undergoing heart surgery, leading to better recovery outcomes.
How similar studies have performed: While similar approaches have been explored, this specific intervention targeting sleep disorders in pediatric cardiac surgery patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
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.