Functional Outcomes in Children Post Critical Illness

NCT ID: NCT03730844

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-13
• Study Completion Date: 2019-07-31

Brief 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.

Detailed 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.

Conditions

Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill children

Children admitted to the PICU.

No interventions assigned to this group

Healthy controls

Healthy controls, not admitted to the PICU, without pre-existing medical conditions.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Anticipated at least 48 hours of PICU stay
• At least 1 organ dysfunction
• Expected to survive to PICU discharge

• No pre-existing medical condition requiring active treatment

Exclusion Criteria

• Amputations
• Pre-existing progressive neuromuscular disease
• Oncological disease
• Premature infants, before corrected gestational age 1 month

Healthy controls group

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

References

Ong C, Lee JH, Wong JJM, Leow MKS, Puthucheary ZA. Skeletal Muscle Changes, Function, and Health-Related Quality of Life in Survivors of Pediatric Critical Illness. Crit Care Med. 2021 Sep 1;49(9):1547-1557. doi: 10.1097/CCM.0000000000004970.

Reference Type: DERIVED

PMID: 33861558 (View on PubMed)

Other Identifiers

2014/2073

Identifier Type: -

Identifier Source: org_study_id