Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06879431 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

StatusRecruiting
PhaseNot applicable
SponsorYan Fuxia
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 31, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Secondary endpoints revised (20)
    v3
  2. Start date: Mar 10, 2025 to Apr 28, 2025
    • Secondary endpoints revised (20)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yan Fuxia
5 trials monitored
See all monitored trials
Heart Disease
8,786 trials monitored
See 412 trials at risk
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). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Trial Details
NCT Number NCT06879431
Lead Sponsor Yan Fuxia
Conditions
(from sponsor)		 Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
Related terms Emergence Delirium, Heart Defects, Congenital, Parasomnias
Enrollment 544 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov