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New treatment option for Delirium - Postoperative
Official title Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
ClinicalTrials.gov ID: NCT06879431
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- Age 0-36 months
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
- Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)
You likely can't join if
- Preoperative use of sleep therapy-related medications
- The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
- History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
- Emergency surgery or preoperative ICU admission
- History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as...
- Combined severe hepatic and renal dysfunction
See the full eligibility criteria
- Age 0-36 months
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
- Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)
- Preoperative use of sleep therapy-related medications
- The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
- History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
- Emergency surgery or preoperative ICU admission
- History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression
- Combined severe hepatic and renal dysfunction
- Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal...
- History of preoperative cerebral ischemia and hypoxia
- Concurrent participation in other clinical trials
- Refusal of the family to sign the informed consent form or poor compliance by the child
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.