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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863299
Collaborator
(none)
240
Enrollment
1
Location
13.4
Anticipated Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study
    Actual Study Start Date :
    Nov 17, 2022
    Anticipated Primary Completion Date :
    Dec 17, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Mean Total Night Sleep Minutes [2023.12.31]

      Mean Total Night Sleep Minutes

    2. Deep sleep time [2023.12.31]

      Deep sleep time

    3. Children sleep habit questionnaire score [2023.12.31]

      Children sleep habit questionnaire score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Fudan University Shanghai China

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    • Study Chair: Ying Gu, Pediatric Hospital Affiliated to Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05863299
    Other Study ID Numbers:
    • CHFudanU
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Critical Illness

    Study Results

    No Results Posted as of May 18, 2023