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

May 24, 2025 updated by: Yan Fuxia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
452

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Message-based bedtime routine group
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
Behavioral: Message-based bedtime routine
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
Other: Sleep hygiene education group
The control group received only sleep hygiene education.
Behavioral: sleep hygiene education
Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of postoperative delirium
Time Frame: Postoperative 7 days
Postoperative 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
Time Frame: Postoperative 7 days
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.
Postoperative 7 days
The incidence of postoperative Liver dysfunction
Time Frame: Postoperative 7 days
Postoperative 7 days
Postoperative sleep quality
Time Frame: Postoperative 7 days or before discharge
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.
Postoperative 7 days or before discharge
The incidence of postoperative Acute kidney injury
Time Frame: Within postoperative 7 days
Within postoperative 7 days
The incidence of Pulmonary complication
Time Frame: Postoperative 7 days
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
one of markers of intestinal injury
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
One of markers of intestinal injury
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
One of markers of intestinal injury
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
One of markers of intestinal injury
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
Postoperative 7 days or before discharge
Levels of inflammatory cytokines
Time Frame: Before surgery, at the end of surgery and 24 hours after surgery
The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.
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
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.
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 total hours needing mechanical ventilation support
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 time spent in the intensive care unit.
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
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
total hospitalization cost divided by total length of stay
admission to discharge, up to 30days
Mechanistic endpoint: Concentration of plasma S-100β protein
Time Frame: Before surgery, at the end of surgery and 24 hours after surgery
S-100β protein was used as a surrogate biomarker for the disruption of the blood-brain barrier.
Before surgery, at the end of surgery and 24 hours after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term Sleep quality score
Time Frame: 30 days, 6 months, 1 year after discharge
guardians scored sleep quality 1-5 using a sleep diary
30 days, 6 months, 1 year after discharge
Readmission rate
Time Frame: 30 days/6 months/1 year after discharge
the rate at which a patient is readmitted to the hospital for the same or a different health problem within 30 days/six months/1 year after discharge
30 days/6 months/1 year after discharge
1-Year Mortality and Survival
Time Frame: 1 year after discharge
The rate at which patients die and survive within 1 year of discharge from the hospital.
1 year after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yan Fuxia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fuxia Yan, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-2603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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