NCT06879431 Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
| NCT ID | NCT06879431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yan Fuxia |
| Condition | Delirium - Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 544 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 544 participants in total. It began in 2025-04-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Fuxia Yan
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06879431 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Delirium - Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06879431 currently recruiting?
Yes, NCT06879431 is actively recruiting participants. Contact the research team at yanfuxia@sina.com for enrollment information.
Where is the NCT06879431 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06879431 clinical trial?
NCT06879431 is sponsored by Yan Fuxia. The principal investigator is Fuxia Yan at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 544 participants.