A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children

Completed

• Conditions: Critical Illness; Child; Sleep Disorder

• Registration Number: NCT05863299
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

This research adopts the uniform parallel hybrid research design; The quantitative data and qualitative data were collected at the same time, and then the quantitative and qualitative data were analyzed respectively. Finally, the two data sets were combined. Comprehensive interpretation of the study issues through complementarity and mutual validation of quantitative and qualitative data.

Detailed Description

With the progress and development of medical technology, the mortality rate of critically ill children continues to decline. To improve the long-term prognosis of children has become a new goal of modern medicine. Sleep disorders in critically ill children are caused by disease factors, the complex environment of ICU, and various treatment factors, which have seriously affected the patient's rehabilitation and long-term quality of life. Attention should be paid to the sleep disorders in critically ill children. At present, the research on sleep disorders in critically ill patients in China is mostly focused on adults, and the critically ill children are rarely involved, and there is no research related to sleep disorders and recovery tracks of critically ill children. This prospective longitudinal mixed study aims to describe the change trajectory of sleep disorder and recovery in critically ill children and provide suggestions for subsequent clinical workers to formulate reasonable intervention measures.

Study Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-18
• Primary Completion: 2023-12-17
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

① Age 3-12 years;

• Children who are conscious during ICU,
• children with Glasgow score of 15

Exclusion Criteria

• (1) did not meet the discharge standards, and asked to be discharged;

  • Children with sleep disorder before admission to PICU, that is, those with baseline CSHQ score > 41;

    • The child had a history of mental illness and cognitive impairment.

      • Children with brain injury, coma, disturbance of consciousness, epilepsy and status epilepticus, obstructive sleep apnea hypopnea syndrome; ⑤ Children with hearing and hearing impairment ⑥ICU stay > 30 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deep sleep time	2023.12.31	Deep sleep time
Mean Total Night Sleep Minutes	2023.12.31	Mean Total Night Sleep Minutes
Children sleep habit questionnaire score	2023.12.31	Children sleep habit questionnaire score

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China