NCT04637113Completed
Singapore's Health Outcomes After Critical Illness in Kids
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
Source: ClinicalTrials.gov · Last updated 7 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 14 Oct 2020
- Start date
- 14 Jan 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- KK Women's and Children's Hospital
- NCT number
- NCT04637113
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 14 Jan 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had participated in the current study in a previous PICU admission within the recruitment period.
Other
- Opted for a "Do Not Resuscitate" status for their child and/or
Criteria the registry did not label
- 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.
Age in the registry: 1 month to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KK Women's and Children's Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.