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Paediatric Early Rehabilitation/Mobilisation During InTensive Care (PERMIT)

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ClinicalTrials.gov Identifier: NCT04110938
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
University of Nottingham
Newcastle University
Northumbria University
University of Cambridge
University of Leeds
Imperial College London
Information provided by (Responsible Party):
University of Birmingham

Tracking Information
First Submitted Date August 14, 2019
First Posted Date October 1, 2019
Last Update Posted Date October 1, 2019
Estimated Study Start Date October 28, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 30, 2019)
  • Incidence rates and ratios of the number of ERM interventions from Day 3 to Day 10 post PICU admission [ Time Frame: 3 weeks ]
    Incidence rates will be calculated and exploratory analysis will be performed to understand factors associated with the incidence of ERM delivery.
  • The cumulative prevalence of ERM for each day in PICU after Day 3 up to Day 10 post-admission [ Time Frame: 3 weeks ]
    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.
  • Factors associated with variability of early rehabilitation and/or mobilisation (ERM) delivery [ Time Frame: 3 weeks ]
    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.
  • To evaluate predictors of ERM provided on Day 3 post-PICU-admission [ Time Frame: 3 weeks ]
    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
  • Dose of ERM per day of PICU admission [ Time Frame: 3 weeks ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Paediatric Early Rehabilitation/Mobilisation During InTensive Care
Official Title Paediatric Early Rehabilitation/Mobilisation During InTensive Care: An Observational Study
Brief 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. 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:

  1. All Children and Young Persons (CYP) (0-<16 years)
  2. Admitted to PICU
  3. 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:

  1. A local decision by a Principal investigator (PI) or treating clinical team not to include patient
  2. 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All Children and Young Persons (CYP) (0-<16 years) admitted to paediatric itnesive care units for 3 days or more
Condition
  • ICU
  • Critical Illness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 30, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All Children and Young Persons (CYP) (0-<16 years)
  • Admitted to PICU
  • Remain within PICU on day 3 post-admission

Exclusion Criteria:

  • Local decision by PI or treating clinical team not to include patient
  • Parent or guardian choose to opt out.
Sex/Gender
Sexes Eligible for Study: All
Ages 38 Weeks to 16 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Barnaby Scholefield, Dr 07968722758 b.scholefield@bham.ac.uk
Contact: Jacqueline Thompson, MPH 012141459107 j.y.thompson@bham.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04110938
Other Study ID Numbers RG_18-161
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Birmingham
Study Sponsor University of Birmingham
Collaborators
  • University of Nottingham
  • Newcastle University
  • Northumbria University
  • University of Cambridge
  • University of Leeds
  • Imperial College London
Investigators
Study Chair: Barnaby Scholefield, Dr Birmingham Women's and Children's Hospital
PRS Account University of Birmingham
Verification Date August 2019