Singapore's Health Outcomes After Critical Illness in Kids

NCT04637113 | Completed

• 1 other identifier: theSHACKStudy:Singapore
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric ALL; Critical Illness; Post Intensive Care Unit Syndrome

Keywords

critical illness; family; race; ethnicity; health outcomes

Outcome Measures

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.

  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.

  baseline and 6 months

Secondary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Study Arms (1)

All patients admitted to the PICU meeting eligible criteria

This is a non-interventional study.

Other: This is a non-interventional study

Interventions

This is a non-interventional study OTHER

This is a non-interventional study.

All patients admitted to the PICU meeting eligible criteria

Eligibility Criteria

• Age: 1 Month - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children age 1 month to 18 years old requiring PICU admission for ≥ 48 hours and their parents.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• University of Plymouth: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (4)

• Manning JC, Pinto NP, Rennick JE, Colville G, Curley MAQ. Conceptualizing Post Intensive Care Syndrome in Children-The PICS-p Framework. Pediatr Crit Care Med. 2018 Apr;19(4):298-300. doi: 10.1097/PCC.0000000000001476.

  PMID: 29406379 BACKGROUND

• Abela KM, Wardell D, Rozmus C, LoBiondo-Wood G. Impact of Pediatric Critical Illness and Injury on Families: An Updated Systematic Review. J Pediatr Nurs. 2020 Mar-Apr;51:21-31. doi: 10.1016/j.pedn.2019.10.013. Epub 2019 Dec 23.

  PMID: 31874458 RESULT

• Poh PF, Lee JH, Sultana R, Manning JC, Carey MC, Latour JM. Physical, Cognitive, Emotional, and Social Health Outcomes of Children in the First 6 Months After Childhood Critical Illness: A Prospective Single-Center Study. Pediatr Crit Care Med. 2024 Dec 1;25(12):1138-1149. doi: 10.1097/PCC.0000000000003622. Epub 2024 Oct 11.

  PMID: 39630545 DERIVED

• Poh PF, Lee JH, Manning JC, Carey MC, Sultana R, Latour JM. Singapore's health outcomes after critical illness in kids: A study protocol exploring health outcomes of families 6 months after critical illness. J Adv Nurs. 2021 Aug;77(8):3531-3541. doi: 10.1111/jan.14911. Epub 2021 Jun 3.

  PMID: 34081353 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Critical Illness

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Fen Poh

  KK Women's and Children's Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: November 19, 2020
• Study Start: January 14, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)