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Completed

NCT Number: NCT04637113

Singapore's Health Outcomes After Critical Illness in Kids

What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge.

Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission.

144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time.

Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Child inclusion criteria:

  • Aged 1 month to 18 years at the point of PICU admission
  • PICU total length of stay (LOS) ≥ 48 hours at the point of PICU discharge

Parents inclusion criteria:

  • (a) Parent or legal guardian; (b) cohabits with the child
  • For the family home to be the planned location following hospital discharge.

Exclusion criteria

  • Opted for a "Do Not Resuscitate" status for their child and/or
  • Had participated in the current study in a previous PICU admission within the recruitment period.

Treatment and study plan

This is a non-interventional study

Other

This is a non-interventional study.

Primary outcomes

  1. To describe and compare the change in total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) in children at baseline from 6 months after PICU discharge.

    Time frame: baseline and 6 months

    The PedsQL instrument consists of 23 items that evaluate 4 domains: physical, emotional, social, and school functioning with summary scores available for physical and psychological health. It is scored using a 5-point Likert scale from 0 (never) to 4 (A lot) with a possible score of 0 to 100.

Secondary outcomes

  1. To determine the correlation between race/ethnicity, children's health baseline, and PICU factors with a total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) after PICU discharge.

    Time frame: 6 months

    The Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) total score will be used to compare the difference between Chinese, Malay, and Indian families. This instrument consists of 23 items that evaluate 4 domains: physical, emotional, social, and school functioning with summary scores available for physical and psychological health. It is scored using a 5-point Likert scale from 0 (never) to 4 (A lot) with a possible score of 0 to 100.

  2. To investigate the risk factors for parental PTSD using the PTSD Checklist for DSM-5 (PCL-5) six months after their child's' PICU discharge.

    Time frame: 6 months

    PTSD Checklist for DSM-5 (PCL-5) assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) symptoms of post-traumatic stress disorder. The 20 items self-report measure is scored on a rating a 5-point Likert scale from 0 (Not at all) to 4 (Extremely). The symptoms severity score ranges from 0-80. A cut-off score between 31-33 is indicative of probable PTSD.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • University of Plymouth

Registry information

Official study title

Singapore's Health Outcomes After Critical Illness in Kids: the SHACK Study: A Longitudinal Mixed-methods Study in Singapore to Explore the Health Outcomes of Children and Their Parents in the First Six Months After PICU Discharge

Acronym: SHACK

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
Nov 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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