Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05388708
Registration number
NCT05388708
Ethics application status
Date submitted
18/05/2022
Date registered
24/05/2022
Date last updated
25/03/2025
Titles & IDs
Public title
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Query!
Scientific title
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Query!
Secondary ID [1]
0
0
R01HL153519-01
Query!
Secondary ID [2]
0
0
HUM00173031
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ASCEND
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome
0
0
Query!
Extracorporeal Membrane Oxygenation
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Complications of newborn
Query!
Injuries and Accidents
0
0
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Devices - ECMO support
Other interventions - PROSpect protocolized therapies
Usual care ECMO Cohort - The cohort will be comprised of 550 patients, aged 14 days to 20 years, who go on extracorporeal membrane oxygenation (ECMO) support due to pediatric acute respiratory distress syndrome (PARDS) at physician discretion. Patients with qualifying PARDS must have one oxygenation index (OI) = 16 or two OIs 12 = to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) = 10 (at least 4 hours apart) or one OI 12 = to \< 16 and one OSI \> 10 (at least 4 hours apart) Subjects must be on mechanical ventilation for less than 240 hours (10 days) prior to cannulation. These measures must be after endotracheal intubation and before ECMO start. Chest radiograph prior to ECMO must show bilateral lung disease.
Subjects cannulated on ECMO for no more than 96 hours prior to gaining consent.
PROSpect protocolized therapies cohort - The cohort will be comprised of 1000 patients, aged 14 days to 20 years, who are endotracheally intubated for PARDS. Patients with qualifying PARDS must have one oxygenation index (OI) = 16 or two OIs 12 = to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) = 10 (at least 4 hours apart) or one OI 12 = to \< 16 and one OSI \> 10 (at least 4 hours apart). These measures must be after endotracheal intubation. Chest radiograph must show bilateral lung disease. Patient must be enrolled in a clinical trial Prone and Oscillation Pediatric Clinical Trial (PROSpect) NCT01515787 which is distinct from ASCEND.
PROSpect is a response adaptive randomized clinical trial, testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in children with severe PARDS. PROSpect manages severe PARDS subjects using a rigorous protocol that reserves ECMO for protocol failure.
Treatment: Devices: ECMO support
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
Other interventions: PROSpect protocolized therapies
PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure.
The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \< 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in functional status
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Primary outcome [2]
0
0
Change in health-related quality of life
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Primary outcome [3]
0
0
The proportion of children with a new morbidity
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Primary outcome [4]
0
0
All-cause mortality at hospital discharge or 90-days
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
90 days after the day of illness on which patients from the two cohorts are matched
Query!
Primary outcome [5]
0
0
Comparative change in one-year functional status
Query!
Assessment method [5]
0
0
This primary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. The outcome compares the change in the functional status as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the functional status scale score. 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.
Query!
Timepoint [5]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Primary outcome [6]
0
0
Comparative change in one-year health-related quality of life
Query!
Assessment method [6]
0
0
This primary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. The outcome compares the change in the health-related quality of life as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the change in the age-appropriate 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.
Query!
Timepoint [6]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [1]
0
0
Change in pediatric overall performance category
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [2]
0
0
Change in pediatric cerebral performance category
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [3]
0
0
Change in breathing support
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [4]
0
0
Change in the psychosocial component of health-related quality of life
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [5]
0
0
Change in the physical component of health-related quality of life
Query!
Assessment method [5]
0
0
This secondary natural history outcome is measured among usual care ECMO patients. The outcome is the change in the physical component of health-related quality of life measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate physical 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 physical component of the PedsQL 4.0 Generic Core Scales is composed of one of the four domains: physical functioning. The PedsQL Infant Scales physical component is composed of two of the five domains: physical functioning and physical symptoms.
Query!
Timepoint [5]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [6]
0
0
Change in child fatigue
Query!
Assessment method [6]
0
0
This secondary natural history outcome is measured among usual care ECMO patients. This outcome is the change in child fatigue measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate PedsQL fatigue scale for acute illness. The PedsQL™ Multi-dimensional Fatigue Scale - Acute Version is an 18-item scale that encompasses three domains: General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue. The scale ranges from 0 to 100, with higher scores indicating fewer problems and better health-related quality of life.
Query!
Timepoint [6]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [7]
0
0
Change in family impact of the child's health
Query!
Assessment method [7]
0
0
This secondary natural history outcome is measured among usual care ECMO patients. This outcome is the change in child fatigue measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate PedsQL fatigue scale for acute illness. The PedsQL™ Family Impact Module - Acute Version is a 36-item scale that encompasses eight domains: Physical Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Communication, Worry, Daily Activities, and Family Relationships. The scale ranges from 0 to 100, with higher scores indicating fewer problems.
Query!
Timepoint [7]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [8]
0
0
Change in one-year functional status of children suffering a neurologic injury
Query!
Assessment method [8]
0
0
This secondary natural history outcome is measured among usual care ECMO patients. A neurologic injury is defined as a new intracranial hemorrhage or stroke recognized on radiologic imaging. This outcome will compare the change in functional status as measured at baseline and 12 months after PICU discharge between those children who suffered a neurologic injury to those who did not. The instrument is the functional status scale score. 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) with total scores ranging from 6 to 30.
Query!
Timepoint [8]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [9]
0
0
Difference between groups in intracranial bleeding or ischemic stroke
Query!
Assessment method [9]
0
0
This secondary comparative short-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the difference in the proportion of matched children who suffer a new intracranial hemorrhage or ischemic stroke (recognized on radiologic imaging) between the two groups.
Query!
Timepoint [9]
0
0
28 days after day in illness patients are matched or during hospitalization
Query!
Secondary outcome [10]
0
0
Difference between groups in pneumothorax
Query!
Assessment method [10]
0
0
This secondary comparative short-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the difference in the proportion of matched children who suffer a pulmonary complication of a new pneumothorax at 28 days between children in the two groups.
Query!
Timepoint [10]
0
0
28 days after day in illness patients are matched or during hospitalization
Query!
Secondary outcome [11]
0
0
Comparative difference in the change in child fatigue
Query!
Assessment method [11]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the change in child fatigue as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the age-appropriate PedsQL fatigue scale for acute illness. The PedsQL™ Multi-dimensional Fatigue Scale - Acute Version is an 18-item scale that encompasses three domains: General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue. The scale ranges from 0 to 100, with higher scores indicating fewer problems and better health-related quality of life.
Query!
Timepoint [11]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [12]
0
0
Comparative difference in the change in family impact of the child's health
Query!
Assessment method [12]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the change in family impact of the child's health as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the PedsQL family impact module for acute illness. The PedsQL™ Family Impact Module - Acute Version is a 36-item scale that encompasses eight domains: Physical Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Communication, Worry, Daily Activities, and Family Relationships. The scale ranges from 0 to 100, with higher scores indicating fewer problems.
Query!
Timepoint [12]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [13]
0
0
Comparative difference in the change in the psychosocial component of health-related quality of life
Query!
Assessment method [13]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the change in the psychosocial component of health-related quality of life as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the age-appropriate psychosocial health summary score from 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 scale ranges 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.
Query!
Timepoint [13]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [14]
0
0
Comparative difference in the in change in the physical component of health-related quality of life
Query!
Assessment method [14]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the change in the physical component of health-related quality of life as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the age-appropriate physical health summary score from 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 physical component of the PedsQL 4.0 Generic Core Scales is composed of one of the four domains: physical functioning. The PedsQL Infant Scales physical component is composed of two of the five domains: physical functioning and physical symptoms.
Query!
Timepoint [14]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [15]
0
0
Comparative change in respiratory support
Query!
Assessment method [15]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. This outcome compares the change in respiratory support as measured at baseline and 12 months after PICU discharge between matched children in the two groups. 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).
Query!
Timepoint [15]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Secondary outcome [16]
0
0
Comparative difference in new morbidity
Query!
Assessment method [16]
0
0
This secondary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. A new morbidity is defined as a change in the functional status scale instrument score by 3 or more, as previously described. This outcome compares the change in the proportion of matched children who acquire a new morbidity as measured at baseline and 12 months after PICU discharge between the two groups. The Functional Status Scale 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) with total scores ranging from 6 to 30.
Query!
Timepoint [16]
0
0
baseline and 1 year after pediatric intensive care unit discharge
Query!
Eligibility
Key inclusion criteria
* Time between intubation and ECMO cannulation is less than 240 hours (10 days)
* ECMO support type is respiratory (VV or VA cannulation)
* Chest radiograph with bilateral lung disease
* Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation:
One OI = 16 or Two OIs = 12 and = 16 at least four hours apart or Two OSIs = 10 at least four hours apart or One OI = 12 and = 16 and One OSI = 10 at least four hours apart
Query!
Minimum age
14
Days
Query!
Query!
Maximum age
20
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Previously enrolled in PROSpect
* Perinatal related lung disease
* Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
* Respiratory failure caused by cardiac failure or fluid overload
* Cyanotic congenital heart disease
* Cardiomyopathy
* Primary pulmonary hypertension (PAH)
* Unilateral lung disease
* Intubated for status asthmaticus
* Obstructive airway disease
* Bronchiolitis obliterans
* Post hematopoietic stem cell transplant
* Post lung transplant
* Home ventilator dependent
* Neuromuscular respiratory failure
* Head trauma: (managed with hyperventilation)
* Intracranial bleeding
* Unstable spine, femur or pelvic fractures
* Acute abdominal process/open abdomen
* Family/medical team have decided to not provide full support
* Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.
* Known pregnancy
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/02/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2027
Query!
Actual
Query!
Sample size
Target
550
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Royal Children's Hospital Melbourne - Melbourne
Query!
Recruitment hospital [2]
0
0
Perth Children's Hospital - Perth
Query!
Recruitment hospital [3]
0
0
Queensland Children's Hospital - South Brisbane
Query!
Recruitment hospital [4]
0
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment postcode(s) [1]
0
0
VIC 3052 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
WA 6009 - Perth
Query!
Recruitment postcode(s) [3]
0
0
QLD 4101 - South Brisbane
Query!
Recruitment postcode(s) [4]
0
0
NSW 2145, - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Hawaii
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Indiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Iowa
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kentucky
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Louisiana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maryland
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Massachusetts
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Michigan
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Minnesota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Missouri
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nebraska
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Mexico
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oregon
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Pennsylvania
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Rhode Island
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Carolina
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
South Dakota
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Tennessee
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Texas
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Utah
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Washington
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Wisconsin
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Alberta
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Ontario
Query!
Country [40]
0
0
Chile
Query!
State/province [40]
0
0
Santiago
Query!
Country [41]
0
0
Colombia
Query!
State/province [41]
0
0
Floridablanca
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Genoa
Query!
Country [43]
0
0
New Zealand
Query!
State/province [43]
0
0
Aukland
Query!
Country [44]
0
0
Portugal
Query!
State/province [44]
0
0
Lisbon
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Barcelona
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Madrid
Query!
Country [47]
0
0
Sweden
Query!
State/province [47]
0
0
Stockholm
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Glasgow
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Leicester
Query!
Country [50]
0
0
United Kingdom
Query!
State/province [50]
0
0
Liverpool
Query!
Country [51]
0
0
United Kingdom
Query!
State/province [51]
0
0
London
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
Newcastle Upon Tyne
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Michigan
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Government body
Query!
Name [1]
0
0
National Heart, Lung, and Blood Institute (NHLBI)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05388708
Query!
Trial related presentations / publications
Fiser DH. Assessing the outcome of pediatric intensive care. J Pediatr. 1992 Jul;121(1):68-74. doi: 10.1016/s0022-3476(05)82544-2. Pollack MM, Holubkov R, Glass P, Dean JM, Meert KL, Zimmerman J, Anand KJ, Carcillo J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Functional Status Scale: new pediatric outcome measure. Pediatrics. 2009 Jul;124(1):e18-28. doi: 10.1542/peds.2008-1987. Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003. Pollack MM, Holubkov R, Funai T, Berger JT, Clark AE, Meert K, Berg RA, Carcillo J, Wessel DL, Moler F, Dalton H, Newth CJ, Shanley T, Harrison RE, Doctor A, Jenkins TL, Tamburro R, Dean JM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment. Crit Care Med. 2015 Aug;43(8):1699-709. doi: 10.1097/CCM.0000000000001081. Keim G, Watson RS, Thomas NJ, Yehya N. New Morbidity and Discharge Disposition of Pediatric Acute Respiratory Distress Syndrome Survivors. Crit Care Med. 2018 Nov;46(11):1731-1738. doi: 10.1097/CCM.0000000000003341. Combes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ryan Barbaro, MD
Query!
Address
0
0
University of Michigan
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Kelli McDonough, MS
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
734-232-1998
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05388708
Download to PDF