ICUPERMITNCT04110938
Paediatric Early Rehabilitation/Mobilisation During InTensive Care
An observational study of ICU and Critical Illness, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Read more about this study
- Who is it for?
- Ages 38 weeks to 16 years
- Conditions the study is for
- ICU, Critical Illness
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 31 Oct 2020
- How long will I take part?
- 3 Weeks
- 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 38 weeks to 16 years
- All sexes
- Child
Study population: All Children and Young Persons (CYP) (0-<16 years) admitted to paediatric itnesive care units for 3 days or more
Who may be able to join
- All Children and Young Persons (CYP) (0-<16 years)
- Admitted to PICU
- Remain within PICU on day 3 post-admission
Who cannot join
- Local decision by PI or treating clinical team not to include patient
- Parent or guardian choose to opt out.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Women's and Children's Hospital PICU
Birmingham, West Midlands, B4 6NH
Barnaby Scholefield, Dr, 7968722758, iia-permitstudy@contacts.bham.ac.uk
Jacqueline Thompson, 012141459107, j.y.thompson@bham.ac.uk
About this study
Official title: Paediatric Early Rehabilitation/Mobilisation During InTensive Care: An Observational Study
In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Although survival rates from PICU are at an all-time high (>96%), low levels of mortality have been offset by an increase in morbidity. The impact of being critically ill and exposed to the PICU is multiple. Weakness, cognitive impairment, organ dysfunction, and psychological problems have been reported to emanate from deconditioning. Subsequently, post-PICU many CYP experience significant and residual physical, cognitive, and psychosocial morbidities that impact on their quality of life. The contemporary focus has turned to the development, testing, and implementation of interventions to minimize the harmful effects of critical care and maximize patient outcomes.
Early rehabilitation and/or mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health professionals from multiple disciplines and care-givers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive).
Read more
Rehabilitation has been shown to improve quality of life and patient outcomes; reduce health inequalities, and make significant savings to the health care system. Benefits have been demonstrated in the use of ERM in adult ICU populations in relation to patient outcomes as well as healthcare utilization. Studies also indicate that the intervention is safe and feasible, reduces delirium and increases ventilator-free days, improves day-to-day functioning and reduces hospital readmissions. However, in the United Kingdom (UK), the understanding of current ERM practices (including content, barriers, facilitators, feasibility, and safety) and their impact on the outcomes of pediatric ICU patients is limited. This has stifled an evidence-based approach to ERM which has resulted in disparity in the adoption and utilization of ERM interventions in PICUs across the UK.
To address this critical gap, the first phase of a four-phase program of the PERMIT study will generate evidence of current PICU ERM practices by conducting a survey and an observational study.
The second phase of the study will involve conducting qualitative workshops to develop a prototype ERM program. Qualitative workshops will also be conducted among key stakeholders (clinicians, parents, CYP) to inform the design of an ERM intervention.
The third phase will investigate this ERM program in a pilot study in UK PICUs and finally, the efficacy of the intervention will be tested using a large scale, definitive randomized controlled trial (RCT).
Read the detailed description
The PERMIT study aims to ascertain current ERM practices within PICU settings and barriers/facilitators to ERM delivery.
The investigators plan to directly observe current ERM practices within UK PICUs, identify patients who do and do not receive ERM, describe the variation between PICUs and factors associated with ERM practices.
Inclusion Criteria:
- All Children and Young Persons (CYP) (0-<16 years)
- Admitted to PICU
- Remain within PICU on day 3 post-admission
The broad inclusion criteria will allow for the observation of all types of patients admitted for PICU care (acute and elective e.g. post-surgical recovery) and all age ranges.
Exclusion criteria:
- A local decision by a Principal investigator (PI) or treating clinical team not to include patient
- Parent or guardian chooses to opt-out
Prospective data about all children admitted to PICU for 3 days or more will be collected. Eligible patients will be identified, screened and enrolled in the study. Posters and patient information leaflets will be provided to parents/legal guardians within participating PICU explaining their rights to withdraw from the study without affecting the future care of their child. Data collected as part of the study will be stored for ten years, in line with Good Clinical Practice (GCP) guidelines. No identifiable data will be collected or shared with the PERMIT study team at any time.
Following the observation of current ERM delivery and identification of patients who may benefit from ERM in selected PICUs, the study investigators will use this information to model how many patients may be available in the UK for a potential future RCT. This will be achieved by modeling patient demographic information with the Paediatric Intensive Care Audit Network (PICANet) dataset.
- Conditions
- ICU, Critical Illness
- Keywords
- PICU, Paediatric, Early mobilisation, Early rehabilitation, Observational
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission
The prevalence and scope of ERM will be described as the proportion of patients with any 'active interaction' delivered on Day 3 post-admission.
Measured: 3 weeks
Secondary outcomes (5)
Incidence rates and ratios of the number of ERM interventions from Day 3 to Day 10 post PICU admission
Incidence rates will be calculated and exploratory analysis will be performed to understand factors associated with the incidence of ERM delivery.
Measured: 3 weeks
The cumulative prevalence of ERM for each day in PICU after Day 3 up to Day 10 post-admission
The cumulative prevalence for each day in PICU after Day 3 up to Day 10 post-admission with whom ERM may/may not be appropriate will be calculated.
Exploratory analysis will be performed to understand factors associated with the incidence of ERM delivery.
Measured: 3 weeks
Factors associated with variability of early rehabilitation and/or mobilisation (ERM) delivery
Exploratory analysis will be performed to understand factors associated with ERM delivery. ERM delivered per patient will be quantified as well as the characteristics of patients receiving ERM, type of ERM interventions delivered and factors associated with variability of delivery between PICUs will be explored.
Measured: 3 weeks
To evaluate predictors of ERM provided on Day 3 post-PICU-admission
Exploratory analysis will be used to explore the characteristics of patients receiving ERM on Day 3 post-PICU-admission.
Multilevel multivariable regression models will be used to evaluate predictors of ERM provision
Measured: 3 weeks
Dose of ERM per day of PICU admission
Exploratory analysis will be performed to quantify the dose (duration, measured in minutes) of ERM for each day over the 3-week period of the study.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start28 Oct 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Oct 2020 (estimated)
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 ICUStudies 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
- 150 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Newcastle University, Northumbria University, University of Cambridge, University of Leeds, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Barnaby Scholefield, Dr, Study chair, Birmingham Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110938
- Sponsor's protocol ID
- RG_18-161
- Acronym
- PERMIT
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scholefield BR, Menzies JC, McAnuff J, Thompson JY, Manning JC, Feltbower RG, Geary M, Lockley S, Morris KP, Moore D, Pathan N, Kirkham F, Forsyth R, Rapley T. Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study. Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.
PubMed 38063184
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Early Rehabilitation/Mobilisation During InTensive Care: An Observational Study
- ClinicalTrials.gov ID
- NCT04110938
- Acronym / sponsor ID
- PERMIT / RG_18-161
- Conditions
- ICU, Critical Illness
- Keywords
- PICU, Paediatric, Early mobilisation, Early rehabilitation, Observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of Nottingham, Newcastle University, Northumbria University, University of Cambridge, University of Leeds, Imperial College London
- Study start
- 28 Oct 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 1 Oct 2019 (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.
In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Although survival rates from PICU are at an all-time high (>96%), low levels of mortality have been offset by an increase in morbidity. The impact of being critically ill and exposed to the PICU is multiple. Weakness, cognitive impairment, organ dysfunction, and psychological problems have been reported to emanate from deconditioning. Subsequently, post-PICU many CYP experience significant and residual physical, cognitive, and psychosocial morbidities that impact on their quality of life. The contemporary focus has turned to the development, testing, and implementation of interventions to minimize the harmful effects of critical care and maximize patient outcomes.
Early rehabilitation and/or mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health professionals from multiple disciplines and care-givers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive).
Rehabilitation has been shown to improve quality of life and patient outcomes; reduce health inequalities, and make significant savings to the health care system. Benefits have been demonstrated in the use of ERM in adult ICU populations in relation to patient outcomes as well as healthcare utilization. Studies also indicate that the intervention is safe and feasible, reduces delirium and increases ventilator-free days, improves day-to-day functioning and reduces hospital readmissions. However, in the United Kingdom (UK), the understanding of current ERM practices (including content, barriers, facilitators, feasibility, and safety) and their impact on the outcomes of pediatric ICU patients is limited. This has stifled an evidence-based approach to ERM which has resulted in disparity in the adoption and utilization of ERM interventions in PICUs across the UK.
To address this critical gap, the first phase of a four-phase program of the PERMIT study will generate evidence of current PICU ERM practices by conducting a survey and an observational study.
The second phase of the study will involve conducting qualitative workshops to develop a prototype ERM program. Qualitative workshops will also be conducted among key stakeholders (clinicians, parents, CYP) to inform the design of an ERM intervention.
The third phase will investigate this ERM program in a pilot study in UK PICUs and finally, the efficacy of the intervention will be tested using a large scale, definitive randomized controlled trial (RCT).
Detailed description
The PERMIT study aims to ascertain current ERM practices within PICU settings and barriers/facilitators to ERM delivery.
The investigators plan to directly observe current ERM practices within UK PICUs, identify patients who do and do not receive ERM, describe the variation between PICUs and factors associated with ERM practices.
Inclusion Criteria:
- All Children and Young Persons (CYP) (0-<16 years)
- Admitted to PICU
- Remain within PICU on day 3 post-admission
The broad inclusion criteria will allow for the observation of all types of patients admitted for PICU care (acute and elective e.g. post-surgical recovery) and all age ranges.
Exclusion criteria:
- A local decision by a Principal investigator (PI) or treating clinical team not to include patient
- Parent or guardian chooses to opt-out
Prospective data about all children admitted to PICU for 3 days or more will be collected. Eligible patients will be identified, screened and enrolled in the study. Posters and patient information leaflets will be provided to parents/legal guardians within participating PICU explaining their rights to withdraw from the study without affecting the future care of their child. Data collected as part of the study will be stored for ten years, in line with Good Clinical Practice (GCP) guidelines. No identifiable data will be collected or shared with the PERMIT study team at any time.
Following the observation of current ERM delivery and identification of patients who may benefit from ERM in selected PICUs, the study investigators will use this information to model how many patients may be available in the UK for a potential future RCT. This will be achieved by modeling patient demographic information with the Paediatric Intensive Care Audit Network (PICANet) dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 38 weeks to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- All Children and Young Persons (CYP) (0-<16 years) admitted to paediatric itnesive care units for 3 days or more
Key inclusion criteria (3 listed)
- All Children and Young Persons (CYP) (0-<16 years)
- Admitted to PICU
- Remain within PICU on day 3 post-admission
Key exclusion criteria (2 listed)
- Local decision by PI or treating clinical team not to include patient
- Parent or guardian choose to opt out.
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
Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission
Time frame: 3 weeks
The prevalence and scope of ERM will be described as the proportion of patients with any 'active interaction' delivered on Day 3 post-admission.
5 secondary outcomes
Incidence rates and ratios of the number of ERM interventions from Day 3 to Day 10 post PICU admission
Time frame: 3 weeks
The cumulative prevalence of ERM for each day in PICU after Day 3 up to Day 10 post-admission
Time frame: 3 weeks
Factors associated with variability of early rehabilitation and/or mobilisation (ERM) delivery
Time frame: 3 weeks
To evaluate predictors of ERM provided on Day 3 post-PICU-admission
Time frame: 3 weeks
Dose of ERM per day of PICU admission
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 38063184Scholefield BR, Menzies JC, McAnuff J, Thompson JY, Manning JC, Feltbower RG, Geary M, Lockley S, Morris KP, Moore D, Pathan N, Kirkham F, Forsyth R, Rapley T. Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study. Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.
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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.
Barnaby Scholefield, Dr study chair
Birmingham 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 ICU and Critical Illness, run by University of Birmingham at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barnaby Scholefield, Dr (07968722758, b.scholefield@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission (time frame: 3 weeks). 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 NCT04110938, 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 1 Oct 2019.