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

NCT ID: NCT05863299

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 247 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2023-12-31

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.

Conditions

Critical Illness; Child; Sleep Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Gu

Role: STUDY_CHAIR

Pediatric Hospital Affiliated to Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

CHFudanU

Identifier Type: -

Identifier Source: org_study_id