NCT03730844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 21, 2020

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

October 25, 2018

Last Update Submit

February 20, 2020

Conditions

Critical Illness

Keywords

Functional outcomesSkeletal muscle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in functional status

    Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge

  • Rectus femoris cross-sectional area

    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

  • Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales

    PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge

  • Caregiver health related quality of life

    Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge

  • Hand grip strength

    Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge

Other Outcomes (1)

  • 24-hour dietary recall

    6-12 months post discharge

Study Arms (2)

Critically ill children

Children admitted to the PICU.

Healthy controls

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Amputations
  • Pre-existing progressive neuromuscular disease
  • Oncological disease
  • Premature infants, before corrected gestational age 1 month
  • Healthy controls group
  • No pre-existing medical condition requiring active treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 33861558DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 5, 2018

Study Start

April 13, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 21, 2020

Record last verified: 2018-10

Locations

SG(1)