Clinical trial NCT05863299: A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children
Official title: Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Child
Sleep Disorder
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 247
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3-12 years chlidren who are conscious in ICU

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.

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.

Primary outcomes:
measure: Mean Total Night Sleep Minutes
timeFrame: 2023.12.31
measure: Deep sleep time
timeFrame: 2023.12.31
measure: Children sleep habit questionnaire score
timeFrame: 2023.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Pediatric Hospital Affiliated to Fudan University
name: Ying Gu
role: STUDY_CHAIR
References: