Improving sleep before heart surgery to reduce delirium in young children

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 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.

Why it matters

Who can join: the full rules

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 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.

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

  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.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT06879431

• 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.