Functional Outcomes in Children Post Critical Illness

Critical Illness Clinical Trial

Official title:

Functional Outcomes in Children Post Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730844
• Other study ID #: 2014/2073
• Status: Completed
• Start date: April 13, 2015
• Est. completion date: July 2019

Study information

• Verified date: October 2018
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Improvements in medical care have led to decreasing mortality rates in critically ill children, which have been reported to be as low as 5%. However, surviving critical illness does not necessarily translate to a return to pre-critical illness functional and developmental levels. Adult literature has shown that critical illness increases functional disability for up to five years post intensive care unit stay. We hypothesize that children experience similar functional disabilities as a result of critical illness, which may, as in adults, be primarily due to muscle wasting. The aim of this prospective observational pilot study is establish the relationship between intensive care unit stay and functional outcomes in pediatric survivors of critical illness.

Description:

Background:

Mortality rates in critically ill children have decreased significantly in recent years, with current rates reported to be as low as 5%. However, increased survival may result in significant morbidity. Herridge et al. demonstrated that adults admitted to the intensive care unit (ICU) for acute respiratory distress syndrome experienced functional disability which persisted up to 5 years after their ICU stay. There now exists a substantial body of literature that adult critical care survivors suffer significant impairment in their quality of life, which is a growing public health issue.

In critically ill children, Namachivayam et al. showed that among children with pediatric intensive care unit (PICU) stay > 28days, 34% of survivors had an unfavourable functional outcome (defined as moderate or severe disability with dependence on others for care as measured by the Glasgow Outcome Scale). Health related quality of life was also affected, with 68% of survivors having poorer quality of life scores as measured by the Health State Utilities Index. Thus, clinicians have argued that mortality may not be the most meaningful outcome measure for PICU patients. Alternative outcome measures such as functional status and quality of life of children post critical illness may give a better overall assessment of how well children cope with surviving critical illness, and how their normal development is affected.

In adults there is a growing understanding of the burden of critical care survivors on families and caregivers. Limited data exists regarding the families and caregivers of survivors of pediatric critical illness, and local data is lacking.

Aim:

The investigator's aim is to assess the impact of critical illness on functional outcomes in survivors of pediatric critical illness, as well as the impact on the caregivers.

Hypotheses:

1. Children surviving critical illness demonstrate significant functional impairment that persists for up to 12 months.

2. Caregivers of children surviving critical illness experience prolonged lower quality of life and significant economic stress.

3. Low muscle mass secondary to muscle wasting is highly associated with said functional disability.

Specific objectives:

1. To describe short and long term functional outcomes in pediatric survivors.

2. To describe the relationship between muscle wasting and functional outcome measures.

3. To elucidate the relationship between pediatric critical illness survivor functional outcomes and caregiver's long term quality of life and lost workdays.

4. To establish the relationship between in-PICU and in-hospital nutrition and physical activity and functional outcomes after a year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Critically ill children group

Inclusion Criteria:

• Anticipated at least 48 hours of PICU stay

• At least 1 organ dysfunction

• Expected to survive to PICU discharge

Exclusion Criteria:

• Amputations

• Pre-existing progressive neuromuscular disease

• Oncological disease

• Premature infants, before corrected gestational age 1 month

Healthy controls group

Inclusion criteria:

• No pre-existing medical condition requiring active treatment

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour dietary recall	Nutritional intake assessed by 24-hour dietary recall	6-12 months post discharge
Primary	Change in functional status	Change in Functional Status Scale (FSS) scores from baseline	PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary	Change in functional status	Change in functional status from baseline, as measured by the Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT).	Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary	Rectus femoris cross-sectional area	Change in cross-sectional area of the rectus femoris measured by ultrasonography from baseline and in comparison to healthy controls	Baseline, Day 3, 7, 10 of PICU stay, PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary	Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales	Patient or proxy-reported health related quality of life measured using the age appropriate PedsQL 4.0 generic module (2 - 18 years) and the PedsQL Infant scales (0 - 24 months). Total scores will be calculated on a scale of 0 - 100 (with 100 being the best possible score).	PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary	Caregiver health related quality of life	Parental health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) questionnaires. SF-36 mental component summary scores (MCS) and physical component summary scores (PCS) will be reported on a scale of 0 - 100 (with 100 being the best possible score).	Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary	Hand grip strength	Hand grip strength test in children 6 years and above, compared to healthy controls	Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge