Pediatric Critical IllnessNCT02148081
Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study
An observational study of Pediatric Critical Illness, run by McMaster University at 2 sites in Canada.
Trial summary
When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Pediatric Critical Illness
- How many people
- 182 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2014to Aug 2016
- 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: In order to enrol children at potential risk for the outcomes of interest, and avoid "healthier" participants with short PICU stays, we considered the following: the patient should have: a) a minimum age (when one is expected to be ambulatory/mobilizing), and b) a threshold severity of illness. In order to understand how different subsets of PICU populations are affected by critical illness, we chose not to restrict the selection of patients to a specific diagnosis, nor did we exclude patients with underlying functional or cognitive abnormalities at baseline. This study will evaluate the epidemiology of recovery in a general critically ill pediatric population over time.
Who may be able to join
- Age over 12 months to 17 years
- Admitted to PICU for at least 48 hours
- ≥ one organ dysfunction on admission
- Informed consent of patient/substitute decision maker, and patient assent were appropriate
Who cannot join
- Patients transferred directly from a neonatal intensive care unit prior to discharge home
- Patients who are already mobilizing well, or are at baseline functional status at time of screening
- Previous enrolment into this study
- Language barrier (i.e. no access to translation services)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital London Health Sciences
London, Ontario
About this study
Official title: Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness.
Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).
Read the detailed description
The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery.
The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view?
Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.
- Conditions
- Pediatric Critical Illness
- Keywords
- pediatrics, critical illness, recovery, function, health
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Recovery
Functional Status will be measured at PICU discharge, 3 and 6 months post discharge using the following measurement tools: Pediatric Evaluation of Disability Inventory (PEDI), and the Participation and Environment Measure - children and youth versions (PEM-CY/YC-PEM).
Measured: In the first 6 months following Pediatric Intensive Care Unit Discharge
Predictors of Functional Recovery
The following hypothesized determinants of functional recovery will be evaluated: age, critical illness severity, pre-admission co-morbid status, PICU discharge functional status, and time to rehabilitation.
Measured: 6 months post PICU discharge
Secondary outcomes (1)
Additional components of functional health
Functional Health Status will be measured using the International Classification of Functioning, Disability and Health (ICF) framework (www.who.int/icidh/). In addition to the primary outcome measurements, the following will be assessed: Caregiver burden using the Pediatric Inventory for Parents; and Health Related Quality of Life using KIDSCREEN. The following secondary outcomes of interest will also be measured: Short-term PICU outcomes (i.e. duration of ventilation, length of stay, severity of organ dysfunction, morbidities attributable to delayed mobilization); mortality, health care utilization, and Pediatric Cerebral performance category and Pediatric Overall Performance scores in the 6 months post PICU discharge.
Measured: The first 6 months post PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionAug 2016
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Children's Hospital, London Health Sciences Centre, Canadian Critical Care Trials Group
- Responsible party
- Sponsor
- Investigators
- Karen Choong, MB, BCh, MSc, Principal investigator, McMaster University; Canadian Critical Care Trials Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148081
- Sponsor's protocol ID
- 14-214
- Status last verified
- Aug 2018
- First submitted
- 20 May 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jarvis JM, Fayed N, Fink EL, Choong K, Khetani MA. Caregiver dissatisfaction with their child's participation in home activities after pediatric critical illness. BMC Pediatr. 2020 Sep 2;20(1):415. doi: 10.1186/s12887-020-02306-3.
PubMed 32878614Jarvis JM, Gurga AR, Lim H, Cameron J, Gorter JW, Choong K, Khetani MA. Caregiver Strategy Use to Promote Children's Home Participation After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Nov;100(11):2144-2150. doi: 10.1016/j.apmr.2019.05.034. Epub 2019 Jul 3.
PubMed 31278925Jarvis JM, Choong K, Khetani MA. Associations of Participation-Focused Strategies and Rehabilitation Service Use With Caregiver Stress After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Apr;100(4):703-710. doi: 10.1016/j.apmr.2018.11.017. Epub 2018 Dec 19.
PubMed 30578773Khetani MA, Albrecht EC, Jarvis JM, Pogorzelski D, Cheng E, Choong K. Determinants of change in home participation among critically ill children. Dev Med Child Neurol. 2018 Aug;60(8):793-800. doi: 10.1111/dmcn.13731. Epub 2018 Mar 25.
PubMed 29574916
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT02148081
- Acronym / sponsor ID
- 14-214
- Conditions
- Pediatric Critical Illness
- Keywords
- pediatrics, critical illness, recovery, function, health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Children's Hospital, London Health Sciences Centre, Canadian Critical Care Trials Group
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- 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.
When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness.
Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).
Detailed description
The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery.
The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view?
Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill children | – | – |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In order to enrol children at potential risk for the outcomes of interest, and avoid "healthier" participants with short PICU stays, we considered the following: the patient should have: a) a minimum age (when one is expected to be ambulatory/mobilizing), and b) a threshold severity of illness. In order to understand how different subsets of PICU populations are affected by critical illness, we chose not to restrict the selection of patients to a specific diagnosis, nor did we exclude patients with underlying functional or cognitive abnormalities at baseline. This study will evaluate the epidemiology of recovery in a general critically ill pediatric population over time.
Key inclusion criteria (4 listed)
- Age over 12 months to 17 years
- Admitted to PICU for at least 48 hours
- ≥ one organ dysfunction on admission
- Informed consent of patient/substitute decision maker, and patient assent were appropriate
Key exclusion criteria (4 listed)
- Patients transferred directly from a neonatal intensive care unit prior to discharge home
- Patients who are already mobilizing well, or are at baseline functional status at time of screening
- Previous enrolment into this study
- Language barrier (i.e. no access to translation services)
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
Functional Recovery
Time frame: In the first 6 months following Pediatric Intensive Care Unit Discharge
Functional Status will be measured at PICU discharge, 3 and 6 months post discharge using the following measurement tools: Pediatric Evaluation of Disability Inventory (PEDI), and the Participation and Environment Measure - children and youth versions (PEM-CY/YC-PEM).
Predictors of Functional Recovery
Time frame: 6 months post PICU discharge
The following hypothesized determinants of functional recovery will be evaluated: age, critical illness severity, pre-admission co-morbid status, PICU discharge functional status, and time to rehabilitation.
1 secondary outcome
Additional components of functional health
Time frame: The first 6 months post PICU 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 17 Aug 2018.
- Derived from this study: PubMed 32878614Jarvis JM, Fayed N, Fink EL, Choong K, Khetani MA. Caregiver dissatisfaction with their child's participation in home activities after pediatric critical illness. BMC Pediatr. 2020 Sep 2;20(1):415. doi: 10.1186/s12887-020-02306-3.
- Derived from this study: PubMed 31278925Jarvis JM, Gurga AR, Lim H, Cameron J, Gorter JW, Choong K, Khetani MA. Caregiver Strategy Use to Promote Children's Home Participation After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Nov;100(11):2144-2150. doi: 10.1016/j.apmr.2019.05.034. Epub 2019 Jul 3.
- Derived from this study: PubMed 30578773Jarvis JM, Choong K, Khetani MA. Associations of Participation-Focused Strategies and Rehabilitation Service Use With Caregiver Stress After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Apr;100(4):703-710. doi: 10.1016/j.apmr.2018.11.017. Epub 2018 Dec 19.
- Derived from this study: PubMed 29574916Khetani MA, Albrecht EC, Jarvis JM, Pogorzelski D, Cheng E, Choong K. Determinants of change in home participation among critically ill children. Dev Med Child Neurol. 2018 Aug;60(8):793-800. doi: 10.1111/dmcn.13731. Epub 2018 Mar 25.
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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.
Karen Choong, MB, BCh, MSc principal investigator
McMaster University; Canadian Critical Care Trials Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Critical Illness, run by McMaster University at 2 sites in Canada.
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 4 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Functional Recovery (time frame: In the first 6 months following Pediatric Intensive Care Unit Discharge). The study lists 2 primary outcomes in all. 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 NCT02148081, 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 17 Aug 2018.