Critical IllnessNCT01724593
Functional Recovery in Critically Ill Children
An observational study of Critical Illness and Children, run by Karen Choong at 1 site in Canada.
Trial summary
Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected… Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Critical Illness, Children
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Nov 2013
- 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: Critically Ill Children
Who may be able to join
- Age over 12 months to 17 years
- PCCU stay of ≥ 48 hours
- Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
- Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
- Informed consent of patient/substitute decision maker.
Who cannot join
- Age: < 12 months or ≥18 years
- Patients admitted to step-down/intermediate care
- Patients transferred from Neonatal intensive care unit and never discharge home.
- Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study
Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:
- Pre-morbid condition
- Age
- Time-to-initiation of acute rehabilitation
- Critical illness disease severity
Read the detailed description
Overall Study objectives:
- To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
- To explore the predictors of impaired functional recovery following immobilization in critically ill children.
Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.
- Conditions
- Critical Illness, Children
- Keywords
- functional recovery, critical illness, pediatrics
- 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 |
|---|---|---|
| Observational Cohort | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.
Measured: 12 months
Secondary outcomes (4)
Functional Recovery
Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)
Measured: Baseline, 3 and 6 month follow-up
Pediatric Critical care Unit (PCCU) clinical outcomes
PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness
Measured: at 30 days and duration of hospitalization
Muscle Strength
In an age-appropriate subgroup, the following measurements will be conducted:
- Muscle Strength and aerobic fitness testing (age ≥ 5 years, and/or able to cognitively and physically comply with strength and fitness tests)
- Measurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)
Measured: Hospital discharge and at 3 and 6 month follow-up
Parental or caregiver stress
Parental or caregiver stress will be measured with the Parental Stress Index (PSI)
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Choong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Choong, McMaster University
- Investigators
- Karen Choong, MB, BCh, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724593
- Sponsor's protocol ID
- HHS REB No. 12-475
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2012
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study
- ClinicalTrials.gov ID
- NCT01724593
- Acronym / sponsor ID
- HHS REB No. 12-475
- Conditions
- Critical Illness, Children
- Keywords
- functional recovery, critical illness, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karen ChoongUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Nov 2012 (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.
Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:
- Pre-morbid condition
- Age
- Time-to-initiation of acute rehabilitation
- Critical illness disease severity
Detailed description
Overall Study objectives:
- To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
- To explore the predictors of impaired functional recovery following immobilization in critically ill children.
Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | –No Intervention |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically Ill Children
Key inclusion criteria (5 listed)
- Age over 12 months to 17 years
- PCCU stay of ≥ 48 hours
- Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
- Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
- Informed consent of patient/substitute decision maker.
Key exclusion criteria (4 listed)
- Age: < 12 months or ≥18 years
- Patients admitted to step-down/intermediate care
- Patients transferred from Neonatal intensive care unit and never discharge home.
- Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening
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
Feasibility
Time frame: 12 months
Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.
4 secondary outcomes
Functional Recovery
Time frame: Baseline, 3 and 6 month follow-up
Pediatric Critical care Unit (PCCU) clinical outcomes
Time frame: at 30 days and duration of hospitalization
Muscle Strength
Time frame: Hospital discharge and at 3 and 6 month follow-up
Parental or caregiver stress
Time frame: 3 month follow-up
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 5 Nov 2013.
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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
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 and Children, run by Karen Choong at 1 site 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 5 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 5 Nov 2013. 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 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?
Feasibility (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2013.