Delirium - PostoperativeNCT06861998
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
A study testing Message-based bedtime routine and sleep hygiene education in people with Delirium - Postoperative and Sleep Problems, run by Yan Fuxia at 1 site in China.
Trial 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 infants and toddlers undergoing congenital heart surgery. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
- What is being tested?
- Message-based bedtime routine and sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-3 years
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
- Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).
Who cannot join
- Infants and toddlers who have taken any relevant preoperative treatment for sleep problems
- The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.
- Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.
- 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)
- Concurrent participation in other clinical trials
- Refusal of the family to sign the informed consent or poor compliance of the child.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037
Fuxia Yan, +861088396628, yanfuxia@sina.com
About this study
Official title: The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial
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 infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Read the detailed description
The study will be carried out in Fuwai Hospital, Chinese Academy of Medical Sciences, Anzhen Hospital Affiliated to Capital Medical University, Fuwai Central China Cardiovascular Hospital, Fuwai Cardiovascular Hospital of Yunnan Province, and Children's Hospital Affiliated to Capital Institute of Pediatrics.
The research process is as follows: Perform routine sleep disorder assessments on pediatric patients visiting the outpatient clinic. Fully inform the guardians of pediatric patients with sleep disorders of all the contents and procedures of this trial. After obtaining informed consent comprehensively and having the informed consent forms signed, conduct further assessments on the pediatric patients to determine whether they meet the inclusion and exclusion criteria. All enrolled children's guardians will receive sleep hygine education in the outpatient clinic. After stratification by research center, the random block is set to 4 - 6, the R will be used to randomly assign subjects to the experimental group and the control group at a 1:1 ratio. After randomization, the children in the experimental group receive behavioral interventions every day before surgery, specifically a bedtime routine based on massage/stroking. Guardians need to strictly implement it and cooperate with the researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). In the control group, parents are provided with sleep hygiene education for infants and toddlers, and no additional intervention measures are applied. To better control the quality of interventions for children aged 0 - 3 in the experimental group, the daily implementation status of parents is counted for the degree of implementation (0 - 100%) in the WeChat mini-program. Guardians record the children's daily sleep diaries (online questionnaires) before surgery. The day before surgery, they fill out the Brief Infant Sleep Questionnaire (BISQ) again and compare it with the baseline situation. After admission, children wear actigraphs until the day of surgery and until discharge after surgery to automatically record sleep-related information. After the children are enrolled in the study, relevant researchers will supervise the implementation of cognitive-behavioral interventions for the children once a day before surgery to ensure that the actigraph device functions properly during hospitalization and remind guardians to record electronic sleep diaries until the night before surgery. Follow-up will be conducted within 7 days after surgery or before discharge to evaluate outcomes such as delirium and pain. The primary outcome is the incidence of postoperative delirium, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis.
- Being tested
- Message-based bedtime routine, sleep hygiene education
- Medical subject headings
- Emergence Delirium, Parasomnias, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message-based bedtime routineBehavioural
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
sleep hygiene educationBehavioural
Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.
| Study group | Role | What they receive |
|---|---|---|
| Message-based bedtime routine group | Experimental | The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message. Receives: Behavioral: Message-based bedtime routine |
| Sleep hygiene education group | Other | The control group received only sleep hygiene education. Receives: Behavioral: sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Measured: Postoperative 7 days
Secondary outcomes (17)
Mechanistic endpoint: Concentration of plasma S-100β protein
S-100β protein was used as a surrogate biomarker for the disruption of the blood-brain barrier.
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Postoperative sleep quality
Postoperative sleep quality was assessed using the Actigraph model wGT3X-BT body movement recorder. The Actigraph model wGT3X-BT was worn from the time of admission to 7 days after surgery in order to assess the sleep quality of the subjects.
Measured: Postoperative 7 days or before discharge
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
The FLACC scale is a simple and effective tool used to assess pain in infants and non-verbal patients. It stands for Face, Legs, Activity, Cry, and Consolability. Each of these five items is scored on a scale of 0 to 2, with a higher score indicating a greater degree of pain. The total FLACC score, ranging from 0 to 10, provides a quick and reliable assessment of the patient's pain level.
Measured: Postoperative 7 days
The incidence of postoperative Acute kidney injury
Measured: Within postoperative 7 days
The incidence of Pulmonary complication
Measured: Postoperative 7 days
The incidence of postoperative Liver dysfunction
Measured: Postoperative 7 days
Concentration of intestinal fatty acid binding protein (I-FABP)
one of markers of intestinal injury
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of zonulin
One of markers of intestinal injury
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide (LPS)
One of markers of intestinal injury
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide binding protein (LBP)
One of markers of intestinal injury
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Types and dosages of drugs used for postoperative sedation and analgesia
Measured: Postoperative 7 days or before discharge
Levels of inflammatory cytokines
The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.
Measured: Before surgery, at the end of surgery and 24 hours after surgery
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR)
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR) are two blood biomarkers based on blood cell counts, which reflect the inflammatory and immune status of the body; they were obtained based on preoperative and postoperative blood routine tests.
Measured: Before surgery, 24 hours after surgery
The duration of postoperative mechanical ventilation
The total hours needing mechanical ventilation support
Measured: From the end of the surgery to discharge from the hospital,up to 30 days
The length of intensive care unit stay
The time spent in the intensive care unit.
Measured: From the end of the surgery to discharge from the hospital,up to 30 days
The length of postoperative hospital stay
Measured: From the end of the surgery to the day of discharge from the hospital,up to 30 days
Average daily cost
total hospitalization cost divided by total length of stay
Measured: admission to discharge, up to 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Fuxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Fuxia Yan, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861998
- Sponsor's protocol ID
- 2025-2603
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06861998
- Acronym / sponsor ID
- 2025-2603
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Yan FuxiaUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Detailed description
The study will be carried out in Fuwai Hospital, Chinese Academy of Medical Sciences, Anzhen Hospital Affiliated to Capital Medical University, Fuwai Central China Cardiovascular Hospital, Fuwai Cardiovascular Hospital of Yunnan Province, and Children's Hospital Affiliated to Capital Institute of Pediatrics.
The research process is as follows: Perform routine sleep disorder assessments on pediatric patients visiting the outpatient clinic. Fully inform the guardians of pediatric patients with sleep disorders of all the contents and procedures of this trial. After obtaining informed consent comprehensively and having the informed consent forms signed, conduct further assessments on the pediatric patients to determine whether they meet the inclusion and exclusion criteria. All enrolled children's guardians will receive sleep hygine education in the outpatient clinic. After stratification by research center, the random block is set to 4 - 6, the R will be used to randomly assign subjects to the experimental group and the control group at a 1:1 ratio. After randomization, the children in the experimental group receive behavioral interventions every day before surgery, specifically a bedtime routine based on massage/stroking. Guardians need to strictly implement it and cooperate with the researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). In the control group, parents are provided with sleep hygiene education for infants and toddlers, and no additional intervention measures are applied. To better control the quality of interventions for children aged 0 - 3 in the experimental group, the daily implementation status of parents is counted for the degree of implementation (0 - 100%) in the WeChat mini-program. Guardians record the children's daily sleep diaries (online questionnaires) before surgery. The day before surgery, they fill out the Brief Infant Sleep Questionnaire (BISQ) again and compare it with the baseline situation. After admission, children wear actigraphs until the day of surgery and until discharge after surgery to automatically record sleep-related information. After the children are enrolled in the study, relevant researchers will supervise the implementation of cognitive-behavioral interventions for the children once a day before surgery to ensure that the actigraph device functions properly during hospitalization and remind guardians to record electronic sleep diaries until the night before surgery. Follow-up will be conducted within 7 days after surgery or before discharge to evaluate outcomes such as delirium and pain. The primary outcome is the incidence of postoperative delirium, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Message-based bedtime routine group | Experimental | Behavioral: Message-based bedtime routineThe intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message. |
| Sleep hygiene education group | Other | Behavioral: sleep hygiene educationThe control group received only sleep hygiene education. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0-3 years
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
- Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).
Key exclusion criteria (6 listed)
- Infants and toddlers who have taken any relevant preoperative treatment for sleep problems
- The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.
- Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.
- 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)
- Concurrent participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Message-based bedtime routineThe intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message. | Behavioural | Message-based bedtime routine group |
| sleep hygiene educationSleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture. | Behavioural | Sleep hygiene education group |
Primary outcome
The incidence of postoperative delirium
Time frame: Postoperative 7 days
17 secondary outcomes
Mechanistic endpoint: Concentration of plasma S-100β protein
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Postoperative sleep quality
Time frame: Postoperative 7 days or before discharge
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
Time frame: Postoperative 7 days
The incidence of postoperative Acute kidney injury
Time frame: Within postoperative 7 days
The incidence of Pulmonary complication
Time frame: Postoperative 7 days
The incidence of postoperative Liver dysfunction
Time frame: Postoperative 7 days
Concentration of intestinal fatty acid binding protein (I-FABP)
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of zonulin
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide (LPS)
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide binding protein (LBP)
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Types and dosages of drugs used for postoperative sedation and analgesia
Time frame: Postoperative 7 days or before discharge
Levels of inflammatory cytokines
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR)
Time frame: Before surgery, 24 hours after surgery
The duration of postoperative mechanical ventilation
Time frame: From the end of the surgery to discharge from the hospital,up to 30 days
The length of intensive care unit stay
Time frame: From the end of the surgery to discharge from the hospital,up to 30 days
The length of postoperative hospital stay
Time frame: From the end of the surgery to the day of discharge from the hospital,up to 30 days
Average daily cost
Time frame: admission to discharge, up to 30days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fuxia Yan principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Message-based bedtime routine and sleep hygiene education in people with Delirium - Postoperative and Sleep Problems, run by Yan Fuxia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuxia Yan (010-88396628, yanfuxia@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.