Clinical trial NCT03730844: Functional Outcomes in Children Post Critical Illness
Official title: Functional Outcomes in Children Post Critical Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Functional outcomes
Skeletal muscle
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-05
Enrollment: 129
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill children will be recruited during their PICU stay at KK Women's and Children's Hospital. They will be followed throughout their PICU stay, at hospital discharge, and 6-12 months post discharge.

Healthy controls will be recruited from the general public by word of mouth. They will undergo assessments at a single time-point.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in functional status
timeFrame: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Secondary outcomes:
measure: Change in functional status
timeFrame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
measure: Rectus femoris cross-sectional area
timeFrame: 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
measure: Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales
timeFrame: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
measure: Caregiver health related quality of life
timeFrame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
measure: Hand grip strength
timeFrame: Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Other outcomes:
measure: 24-hour dietary recall
timeFrame: 6-12 months post discharge
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
citation: 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.