Critical IllnessNCT03730844
Functional Outcomes in Children Post Critical Illness
An observational study of Critical Illness, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Improvements in medical care have led to decreasing mortality rates in critically ill children, which have been reported to be as low as 5%. However, surviving critical illness does not necessarily translate to a return to pre-critical illness functional and developmental levels. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- How many people
- 129 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Apr 2015to Jul 2019
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Critically ill children will be recruited during their PICU stay at KK Women's and Children's Hospital. They will be followed throughout their PICU stay, at hospital discharge, and 6-12 months post discharge. Healthy controls will be recruited from the general public by word of mouth. They will undergo assessments at a single time-point.
Who may be able to join
- Anticipated at least 48 hours of PICU stay
- At least 1 organ dysfunction
- Expected to survive to PICU discharge
- No pre-existing medical condition requiring active treatment
Who cannot join
- Amputations
- Pre-existing progressive neuromuscular disease
- Oncological disease
- Premature infants, before corrected gestational age 1 month
- Healthy controls group
Trial locations and contacts
1 site in 1 country.
About this study
Improvements in medical care have led to decreasing mortality rates in critically ill children, which have been reported to be as low as 5%. However, surviving critical illness does not necessarily translate to a return to pre-critical illness functional and developmental levels. Adult literature has shown that critical illness increases functional disability for up to five years post intensive care unit stay. We hypothesize that children experience similar functional disabilities as a result of critical illness, which may, as in adults, be primarily due to muscle wasting. The aim of this prospective observational pilot study is establish the relationship between intensive care unit stay and functional outcomes in pediatric survivors of critical illness.
Read the detailed description
Background:
Mortality rates in critically ill children have decreased significantly in recent years, with current rates reported to be as low as 5%. However, increased survival may result in significant morbidity. Herridge et al. demonstrated that adults admitted to the intensive care unit (ICU) for acute respiratory distress syndrome experienced functional disability which persisted up to 5 years after their ICU stay. There now exists a substantial body of literature that adult critical care survivors suffer significant impairment in their quality of life, which is a growing public health issue.
In critically ill children, Namachivayam et al. showed that among children with pediatric intensive care unit (PICU) stay > 28days, 34% of survivors had an unfavourable functional outcome (defined as moderate or severe disability with dependence on others for care as measured by the Glasgow Outcome Scale). Health related quality of life was also affected, with 68% of survivors having poorer quality of life scores as measured by the Health State Utilities Index. Thus, clinicians have argued that mortality may not be the most meaningful outcome measure for PICU patients. Alternative outcome measures such as functional status and quality of life of children post critical illness may give a better overall assessment of how well children cope with surviving critical illness, and how their normal development is affected.
In adults there is a growing understanding of the burden of critical care survivors on families and caregivers. Limited data exists regarding the families and caregivers of survivors of pediatric critical illness, and local data is lacking.
Aim:
The investigator's aim is to assess the impact of critical illness on functional outcomes in survivors of pediatric critical illness, as well as the impact on the caregivers.
Hypotheses:
- Children surviving critical illness demonstrate significant functional impairment that persists for up to 12 months.
- Caregivers of children surviving critical illness experience prolonged lower quality of life and significant economic stress.
- Low muscle mass secondary to muscle wasting is highly associated with said functional disability.
Specific objectives:
- To describe short and long term functional outcomes in pediatric survivors.
- To describe the relationship between muscle wasting and functional outcome measures.
- To elucidate the relationship between pediatric critical illness survivor functional outcomes and caregiver's long term quality of life and lost workdays.
- To establish the relationship between in-PICU and in-hospital nutrition and physical activity and functional outcomes after a year.
- Conditions
- Critical Illness
- Keywords
- Functional outcomes, Skeletal muscle
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill children | Children admitted to the PICU. | |
| Healthy controls | Healthy controls, not admitted to the PICU, without pre-existing medical conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional status
Change in Functional Status Scale (FSS) scores from baseline
Measured: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary outcomes (5)
Change in functional status
Change in functional status from baseline, as measured by the Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT).
Measured: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Rectus femoris cross-sectional area
Change in cross-sectional area of the rectus femoris measured by ultrasonography from baseline and in comparison to healthy controls
Measured: Baseline, Day 3, 7, 10 of PICU stay, PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales
Patient or proxy-reported health related quality of life measured using the age appropriate PedsQL 4.0 generic module (2 - 18 years) and the PedsQL Infant scales (0 - 24 months). Total scores will be calculated on a scale of 0 - 100 (with 100 being the best possible score).
Measured: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Caregiver health related quality of life
Parental health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) questionnaires. SF-36 mental component summary scores (MCS) and physical component summary scores (PCS) will be reported on a scale of 0 - 100 (with 100 being the best possible score).
Measured: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Hand grip strength
Hand grip strength test in children 6 years and above, compared to healthy controls
Measured: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start13 Apr 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730844
- Sponsor's protocol ID
- 2014/2073
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ong C, Lee JH, Wong JJM, Leow MKS, Puthucheary ZA. Skeletal Muscle Changes, Function, and Health-Related Quality of Life in Survivors of Pediatric Critical Illness. Crit Care Med. 2021 Sep 1;49(9):1547-1557. doi: 10.1097/CCM.0000000000004970.
PubMed 33861558
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in Children Post Critical Illness
- ClinicalTrials.gov ID
- NCT03730844
- Acronym / sponsor ID
- 2014/2073
- Conditions
- Critical Illness
- Keywords
- Functional outcomes, Skeletal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 13 Apr 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 5 Nov 2018 (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.
Improvements in medical care have led to decreasing mortality rates in critically ill children, which have been reported to be as low as 5%. However, surviving critical illness does not necessarily translate to a return to pre-critical illness functional and developmental levels. Adult literature has shown that critical illness increases functional disability for up to five years post intensive care unit stay. We hypothesize that children experience similar functional disabilities as a result of critical illness, which may, as in adults, be primarily due to muscle wasting. The aim of this prospective observational pilot study is establish the relationship between intensive care unit stay and functional outcomes in pediatric survivors of critical illness.
Detailed description
Background:
Mortality rates in critically ill children have decreased significantly in recent years, with current rates reported to be as low as 5%. However, increased survival may result in significant morbidity. Herridge et al. demonstrated that adults admitted to the intensive care unit (ICU) for acute respiratory distress syndrome experienced functional disability which persisted up to 5 years after their ICU stay. There now exists a substantial body of literature that adult critical care survivors suffer significant impairment in their quality of life, which is a growing public health issue.
In critically ill children, Namachivayam et al. showed that among children with pediatric intensive care unit (PICU) stay > 28days, 34% of survivors had an unfavourable functional outcome (defined as moderate or severe disability with dependence on others for care as measured by the Glasgow Outcome Scale). Health related quality of life was also affected, with 68% of survivors having poorer quality of life scores as measured by the Health State Utilities Index. Thus, clinicians have argued that mortality may not be the most meaningful outcome measure for PICU patients. Alternative outcome measures such as functional status and quality of life of children post critical illness may give a better overall assessment of how well children cope with surviving critical illness, and how their normal development is affected.
In adults there is a growing understanding of the burden of critical care survivors on families and caregivers. Limited data exists regarding the families and caregivers of survivors of pediatric critical illness, and local data is lacking.
Aim:
The investigator's aim is to assess the impact of critical illness on functional outcomes in survivors of pediatric critical illness, as well as the impact on the caregivers.
Hypotheses:
- Children surviving critical illness demonstrate significant functional impairment that persists for up to 12 months.
- Caregivers of children surviving critical illness experience prolonged lower quality of life and significant economic stress.
- Low muscle mass secondary to muscle wasting is highly associated with said functional disability.
Specific objectives:
- To describe short and long term functional outcomes in pediatric survivors.
- To describe the relationship between muscle wasting and functional outcome measures.
- To elucidate the relationship between pediatric critical illness survivor functional outcomes and caregiver's long term quality of life and lost workdays.
- To establish the relationship between in-PICU and in-hospital nutrition and physical activity and functional outcomes after a year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill children | – | –Children admitted to the PICU. |
| Healthy controls | – | –Healthy controls, not admitted to the PICU, without pre-existing medical conditions. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Critically ill children will be recruited during their PICU stay at KK Women's and Children's Hospital. They will be followed throughout their PICU stay, at hospital discharge, and 6-12 months post discharge. Healthy controls will be recruited from the general public by word of mouth. They will undergo assessments at a single time-point.
Key inclusion criteria (4 listed)
- Anticipated at least 48 hours of PICU stay
- At least 1 organ dysfunction
- Expected to survive to PICU discharge
- No pre-existing medical condition requiring active treatment
Key exclusion criteria (5 listed)
- Amputations
- Pre-existing progressive neuromuscular disease
- Oncological disease
- Premature infants, before corrected gestational age 1 month
- Healthy controls group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in functional status
Time frame: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Change in Functional Status Scale (FSS) scores from baseline
5 secondary outcomes
Change in functional status
Time frame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Rectus femoris cross-sectional area
Time frame: Baseline, Day 3, 7, 10 of PICU stay, PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales
Time frame: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Caregiver health related quality of life
Time frame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Hand grip strength
Time frame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
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 21 Feb 2020.
- Derived from this study: PubMed 33861558Ong C, Lee JH, Wong JJM, Leow MKS, Puthucheary ZA. Skeletal Muscle Changes, Function, and Health-Related Quality of Life in Survivors of Pediatric Critical Illness. Crit Care Med. 2021 Sep 1;49(9):1547-1557. doi: 10.1097/CCM.0000000000004970.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 4 inclusion and 5 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 21 Feb 2020. 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?
Change in functional status (time frame: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge). 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 NCT03730844, which also lists 1 linked publication.
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 21 Feb 2020.