Overview

This trial is active, not recruiting.

Condition pediatric critical illness
Sponsor McMaster University
Collaborator McMaster Children's Hospital
Start date August 2014
End date July 2016
Trial size 182 participants
Trial identifier NCT02148081, 14-214

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. 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Functional Recovery
time frame: In the first 6 months following Pediatric Intensive Care Unit Discharge
Predictors of Functional Recovery
time frame: 6 months post PICU discharge

Secondary Outcomes

Measure
Additional components of functional health
time frame: The first 6 months post PICU discharge

Eligibility Criteria

Male or female participants from 12 months up to 17 years old.

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)

Additional Information

Official title Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
Principal investigator Karen Choong, MB, BCh, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by McMaster University.