Singapore's Health Outcomes After Critical Illness in Kids

NCT ID: NCT04637113

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-14

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric ALL Critical Illness Post Intensive Care Unit Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients admitted to the PICU meeting eligible criteria

This is a non-interventional study.

This is a non-interventional study

Intervention Type OTHER

This is a non-interventional study.

Interventions

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This is a non-interventional study

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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


* (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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Plymouth

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pei-Fen Poh

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital, Singapore

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 29406379 (View on PubMed)

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.

Reference Type RESULT
PMID: 31874458 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39630545 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34081353 (View on PubMed)

Other Identifiers

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theSHACKStudy:Singapore

Identifier Type: -

Identifier Source: org_study_id

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