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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

Titles & IDs
Public title
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Scientific title
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Secondary ID [1] 0 0
R01HL153519-01
Secondary ID [2] 0 0
HUM00173031
Universal Trial Number (UTN)
Trial acronym
ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome 0 0
Extracorporeal Membrane Oxygenation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in functional status
Timepoint [1] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Primary outcome [2] 0 0
Change in health-related quality of life
Timepoint [2] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Primary outcome [3] 0 0
The proportion of children with a new morbidity
Timepoint [3] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Primary outcome [4] 0 0
All-cause mortality at hospital discharge or 90-days
Timepoint [4] 0 0
90 days after the day of illness on which patients from the two cohorts are matched
Primary outcome [5] 0 0
Comparative change in one-year functional status
Timepoint [5] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Primary outcome [6] 0 0
Comparative change in one-year health-related quality of life
Timepoint [6] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [1] 0 0
Change in pediatric overall performance category
Timepoint [1] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [2] 0 0
Change in pediatric cerebral performance category
Timepoint [2] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [3] 0 0
Change in breathing support
Timepoint [3] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [4] 0 0
Change in the psychosocial component of health-related quality of life
Timepoint [4] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [5] 0 0
Change in the physical component of health-related quality of life
Timepoint [5] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [6] 0 0
Change in child fatigue
Timepoint [6] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [7] 0 0
Change in family impact of the child's health
Timepoint [7] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [8] 0 0
Change in one-year functional status of children suffering a neurologic injury
Timepoint [8] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [9] 0 0
Difference between groups in intracranial bleeding or ischemic stroke
Timepoint [9] 0 0
28 days after day in illness patients are matched or during hospitalization
Secondary outcome [10] 0 0
Difference between groups in pneumothorax
Timepoint [10] 0 0
28 days after day in illness patients are matched or during hospitalization
Secondary outcome [11] 0 0
Comparative difference in the change in child fatigue
Timepoint [11] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [12] 0 0
Comparative difference in the change in family impact of the child's health
Timepoint [12] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [13] 0 0
Comparative difference in the change in the psychosocial component of health-related quality of life
Timepoint [13] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [14] 0 0
Comparative difference in the in change in the physical component of health-related quality of life
Timepoint [14] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [15] 0 0
Comparative change in respiratory support
Timepoint [15] 0 0
baseline and 1 year after pediatric intensive care unit discharge
Secondary outcome [16] 0 0
Comparative difference in new morbidity
Timepoint [16] 0 0
baseline and 1 year after pediatric intensive care unit discharge

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
Minimum age
14 Days
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Children's Hospital Melbourne - Melbourne
Recruitment hospital [2] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
VIC 3052 - Melbourne
Recruitment postcode(s) [2] 0 0
WA 6009 - Perth
Recruitment postcode(s) [3] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
NSW 2145, - Westmead
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Newcastle Upon Tyne
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Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Michigan
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ryan Barbaro, MD
Address 0 0
University of Michigan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kelli McDonough, MS
Address 0 0
Country 0 0
Phone 0 0
734-232-1998
Fax 0 0
Email 0 0
kellimcd@umich.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
It is the National Institutes of Health (NIH) policy that the results and accomplishments of the activities that it funds should be made available to the public (see https://grants.nih.gov/policy/sharing.htm).

After the study is completed, the de-identified, archived data will be transmitted to and stored at the Biologic Specimen and Data Repository Information Coordination Center (BioLINCC), for use by other researchers including those outside of the study. Permission to transmit data to the BioLINCC will be included in the informed consent.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Two years after study analysis is complete.
Available to whom?
ASCEND investigators will compose the ASCEND steering committee lead by PI Barbaro. Members include Ryan Barbaro, Theodore Iwashyna, Martha Curley, Carol Hodgson, Seth Warschausky and Ben Hansen. The steering committee will be responsible for developing publication procedures and resolving authorship issues.
Available for what types of analyses?
How or where can data be obtained?


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