Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study

NCT ID: NCT02148081

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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

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Pediatric Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

12 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster Children's Hospital

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Choong, MB, BCh, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Canadian Critical Care Trials Group

Locations

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McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status

Children's Hospital London Health Sciences

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32878614 (View on PubMed)

Jarvis 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.

Reference Type DERIVED
PMID: 31278925 (View on PubMed)

Jarvis 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.

Reference Type DERIVED
PMID: 30578773 (View on PubMed)

Khetani 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.

Reference Type DERIVED
PMID: 29574916 (View on PubMed)

Other Identifiers

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14-214

Identifier Type: -

Identifier Source: org_study_id

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