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

Critical Illness Clinical Trial

Official title:

Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05863299
• Other study ID #: CHFudanU
• Status: Completed
• Start date: November 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 31, 2023
• Est. primary completion date: December 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

? 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; ? Children with hearing and hearing impairment ?ICU stay > 30 days.

Related Conditions & MeSH terms

• Child
• Critical Illness
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Total Night Sleep Minutes	Mean Total Night Sleep Minutes	2023.12.31
Primary	Deep sleep time	Deep sleep time	2023.12.31
Primary	Children sleep habit questionnaire score	Children sleep habit questionnaire score	2023.12.31