Pediatric ALLSHACKNCT04637113
Singapore's Health Outcomes After Critical Illness in Kids
An observational study of Pediatric ALL and Critical Illness, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Critical Illness, Post Intensive Care Unit Syndrome
- What is being tested?
- This is a non-interventional study
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children age 1 month to 18 years old requiring PICU admission for ≥ 48 hours and their parents.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Being tested
- This is a non-interventional study
- Keywords
- critical illness, family, race, ethnicity, health outcomes
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| All patients admitted to the PICU meeting eligible criteria | This is a non-interventional study. Receives: Other: This is a non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start14 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- University of Plymouth
- Responsible party
- Sponsor
- Investigators
- Pei-Fen Poh, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637113
- Sponsor's protocol ID
- theSHACKStudy:Singapore
- Acronym
- SHACK
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2020
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29406379Abela 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.
PubMed 31874458Poh 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.
PubMed 39630545Poh 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.
PubMed 34081353
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04637113
- Acronym / sponsor ID
- SHACK / theSHACKStudy:Singapore
- Keywords
- critical illness, family, race, ethnicity, health outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- University of Plymouth
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients admitted to the PICU meeting eligible criteria | – | Other: This is a non-interventional studyThis is a non-interventional study. |
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children age 1 month to 18 years old requiring PICU admission for ≥ 48 hours and their parents.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyThis is a non-interventional study. | Other | All patients admitted to the PICU meeting eligible criteria |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 29406379Manning 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.
- Results publication: PubMed 31874458Abela 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.
- Derived from this study: PubMed 39630545Poh 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.
- Derived from this study: PubMed 34081353Poh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fen Poh principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL and Critical Illness, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.