Pre-surgery sleep program to reduce delirium after congenital heart surgery in infants and toddlers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving sleep before heart surgery to reduce delirium in young children

  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.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT06861998

• Sleep problems before heart surgery may affect recovery outcomes

  This study tests whether preoperative sleep issues in adults undergoing cardiac surgery are linked to different perioperative metabolites and postoperative outcomes.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality · NCT07588178

• Personalized iPad audio messages to reduce confusion after hip fracture surgery

  This trial will try 2-minute personalized audio reorientation messages on an iPad to see if they help prevent confusion (delirium) in people aged 60 and over after hip fracture surgery.

  Recruiting Sengkang General Hospital · Singapore · NCT07396532

• Impact of Fast-Track Anesthesia on Postoperative Delirium After Cardiac Surgery

  This observational study tests whether fast-track anesthesia, compared with conventional care, is linked to lower rates of delirium after elective cardiac surgery in adults.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07923344

• Remimazolam vs. Propofol for Sedation After Cardiac Surgery in Older Adults

  This trial tests whether remimazolam tosylate can lower the rate of postoperative delirium compared with propofol in patients 65 and older after cardiac surgery with bypass.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07908121

• Dexmedetomidine to See if Delirium Drops After Hip Fracture Surgery

  This observational study tests whether using dexmedetomidine around hip fracture surgery helps prevent postoperative delirium in adults 65 and older.

  Recruiting Aarhus University Hospital · Aarhus · NCT07867899

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.