Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery

Launched by YAN FUXIA · Mar 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether helping infants and toddlers sleep better before heart surgery can prevent them from experiencing confusion or delirium after the surgery. The study will include young children aged 0 to 3 years who have sleep problems and are scheduled for corrective surgery for congenital heart disease. Eligible children will be randomly placed in one of two groups: one group will receive special bedtime routines along with sleep education, while the other will only get sleep education.

Families interested in this study should know that it focuses on children with specific sleep issues, like difficulty falling asleep or staying asleep, as identified by a simple screening tool. The main goal is to see if the sleep routines help reduce the chances of delirium and improve recovery after surgery. This study will also look at how well the children sleep after surgery, their pain levels, and any potential effects on their organs during recovery. It's a great opportunity to contribute to improving care for children with heart conditions.

Gender

ALL

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.