ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

Change in functional status

This primary natural history outcome is measured among usual care extracorporeal membrane oxygenation (ECMO) patients. This outcome is the change in functional status as measured at baseline and 12 months after pediatric intensive care unit (PICU) discharge. The instrument is the functional status scale score. The baseline measure will be made within 96 hours of ECMO initiation and reflect patient's status in the week prior to ECMO. The Functional Status Scale (FSS) is a valid and reliable assessment method to quantify functional status. The FSS includes 6 domains: mental status, sensory functioning, communication, motor function, feeding, and respiratory. Scores for each domain range from 1 (normal) to 5 (very severe dysfunction); total scores range from 6 to 30 with higher scores reflecting worse functioning.

Change in health-related quality of life

This primary natural history outcome is measured among usual care ECMO patients. This outcome is the change in the health-related quality of life as measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate Version 4.0 Pediatric Quality of Life Inventory (PedsQL 4.0) generic core scales for acute illness. PedsQL 4.0 Generic Core Scales and Infant Scales - Acute Version are parent proxy-report scales. The scales ranges from 0 to 100, with higher scores indicating fewer problems. PedsQL 4.0 Generic Core Scales is a 23-item scale with 4 domains: physical functioning, emotional functioning, social functioning, and school functioning. The PedsQL Infant Scales consist of 36-45 questions, depending on age, with 5 domains: physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning.

The proportion of children with a new morbidity

This primary natural history outcome is measured among usual care ECMO patients. A new morbidity is defined as a change in the functional status scale score instrument by 3 or more, as previously described. This outcome will report the proportion of children who acquire a new morbidity as measured at baseline and 12 months after PICU discharge. The Functional Status Scale (FSS) is a valid and reliable assessment method to quantify functional status. The FSS includes 6 domains: mental status, sensory functioning, communication, motor function, feeding, and respiratory. Scores for each domain range from 1 (normal) to 5 (very severe dysfunction); total scores range from 6 to 30 with higher scores reflecting worse functioning.

All-cause mortality at hospital discharge or 90-days

This primary comparative short-term outcome is measured among both usual care ECMO and Prone and Oscillation Pediatric Clinical Trial (PROSpect) protocolized therapy groups. The outcome compares the 90-day mortality for matched children in the two groups. The endpoint is 90 days after the day of illness on which patients from the two cohorts are matched or hospital discharge.

Change in pediatric overall performance category

This secondary natural history outcome is measured among usual care ECMO patients. The outcome is the change in the pediatric overall performance category measured at baseline and 12 months after PICU discharge. The instrument is the pediatric overall performance category. The Pediatric Overall Performance Category (POPC) quantifies impairments and functional morbidity. Scores range from 1 to 6 with 1: good, 2: mild disability, 3: moderate disability, 4: severe disability, 5: coma, and 6: brain death.

Change in pediatric cerebral performance category

This secondary natural history outcome is measured among usual care ECMO patients. This outcome is the change in the pediatric cerebral performance category measured at baseline and 12 months after PICU discharge. The instrument is the pediatric cerebral performance category. The Pediatric Cerebral Performance Category (PCPC) quantifies cognitive impairments. Scores range from 1 to 6 with 1: good, 2: mild disability, 3: moderate disability, 4: severe disability, 5: coma, and 6: brain death.

Change in breathing support

This secondary natural history outcome is measured among usual care ECMO patients. This outcome is the change in breathing support measured at baseline and 12 months after PICU discharge. The instrument is the respiratory subscale of the functional status scale score. The Functional Status Scale (FSS) is a valid and reliable assessment method to quantify functional status with 6 domains. This measure of breathing support will rely on the FSS respiratory domain. The respiratory domain score ranges from 1 (normal) to 5 (very severe dysfunction).

Change in the psychosocial component of health-related quality of life

This secondary natural history outcome is measured among usual care ECMO patients. This outcome is the change in the psychosocial component of health-related quality of life measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate psychosocial health summary score of the PedsQL 4.0 generic core scales for acute illness. PedsQL 4.0 Generic Core Scales and Infant Scales - Acute Version are parent proxy-report scales. The scales range from 0 to 100, with higher scores indicating fewer problems. The psychosocial component of the PedsQL 4.0 Generic Core Scales is composed of three of the four domains: emotional functioning, social functioning, and school functioning. The PedsQL Infant Scales psychosocial component is composed of three of the five domains: emotional functioning, social functioning, and cognitive functioning.