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Completed

NCT Number: NCT05863299

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

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.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean Total Night Sleep Minutes

    Time frame: 2023.12.31

    Mean Total Night Sleep Minutes

  2. Deep sleep time

    Time frame: 2023.12.31

    Deep sleep time

  3. Children sleep habit questionnaire score

    Time frame: 2023.12.31

    Children sleep habit questionnaire score

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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