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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03896763




Registration number
NCT03896763
Ethics application status
Date submitted
22/10/2018
Date registered
1/04/2019

Titles & IDs
Public title
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Scientific title
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Secondary ID [1] 0 0
5UH3HL141736-03
Secondary ID [2] 0 0
831295
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome in Children 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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Either supine or prone positioning and either CMV or HFOV

Experimental: Supine / CMV - Supine positioning and conventional mechanical ventilation

Experimental: Prone / CMV - Prone positioning and conventional mechanical ventilation

Experimental: Supine / HVOF - Supine positioning and high-frequency oscillatory ventilation

Experimental: Prone / HFOV - Prone positioning and high-frequency oscillatory ventilation


Other interventions: Either supine or prone positioning and either CMV or HFOV
Supine positioning: Subjects randomized to supine positioning will remain supine.

Prone positioning: Subjects randomized to prone positioning will be positioned prone =16 hours/day for a maximum of 28 days.

CMV strategy: Low tidal volume to obtain exhaled Vt of 5-7 ml/kg (ideal body weight), PIP goal limited to = 28 cm H2O and lung recruitment maneuver to identify best PEEP then maintained per PEEP-FiO2 grid.

HFOV strategy: Frequency at 8-12 Hz, amplitude (delta-P) 60-90 and mPaw recruitment maneuver.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ventilator-free Days (VFD)
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Nonpulmonary organ failure-free days (OFFD)
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
Inclusion criteria:

Intubated and mechanically ventilated with high moderate-severe PARDS for <48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI =12 or OSI =10). We require two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume). A second blood gas is not required for OI =16.
Minimum age
2 Weeks
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Perinatal related lung disease
* Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
* Respiratory failure explained by cardiac failure or fluid overload
* Cyanotic heart disease
* Cardiomyopathy
* Unilateral lung disease
* Primary pulmonary hypertension
* Intubated for status asthmaticus
* Obstructive airway disease (e.g., Severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 <0.30 and/or evidence of increased resistance visible on the flow - time scalar and/or presence of intrinsic PEEP)
* Active air leak
* Bronchiolitis obliterans
* Post hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at time of meeting inclusion criteria; spending more than four days in the PICU prior to intubation; supported on or with immediate plans for renal replacement therapies; with two or more allogeneic transplants; who relapsed after the transplant; or with diffuse alveolar hemorrhage
* Post lung transplant
* Home ventilator dependent with baseline Oxygen Saturation Index (OSI) >6
* Neuromuscular respiratory failure
* Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
* Facial surgery or trauma in previous 2 weeks
* Head trauma (managed with hyperventilation)
* Intracranial bleeding
* Unstable spine, femur or pelvic fractures
* Open abdomen
* Currently receiving more than 6 consecutive hours of either prone positioning or HFOV
* Supported on ECMO during the current admission
* Family/medical team not providing full support (patient treatment considered futile)
* Previously enrolled in current study
* Enrolled in any other interventional clinical trial not approved for co-enrollment
* Known pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [3] 0 0
Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
- South Brisbane
Recruitment postcode(s) [2] 0 0
6840 - Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
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United States of America
State/province [6] 0 0
Indiana
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United States of America
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Iowa
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United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
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Maryland
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United States of America
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Michigan
Country [11] 0 0
United States of America
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Nebraska
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
India
State/province [24] 0 0
Hyderabad
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Italy
State/province [26] 0 0
Bologna
Country [27] 0 0
Italy
State/province [27] 0 0
Florence
Country [28] 0 0
Italy
State/province [28] 0 0
Genova
Country [29] 0 0
Italy
State/province [29] 0 0
Rome
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Netherlands
State/province [31] 0 0
Groningen
Country [32] 0 0
New Zealand
State/province [32] 0 0
Auckland
Country [33] 0 0
Spain
State/province [33] 0 0
Barakaldo
Country [34] 0 0
Thailand
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Bangkok
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United Arab Emirates
State/province [35] 0 0
Abu Dhabi
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United Kingdom
State/province [36] 0 0
UK
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pennsylvania
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
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Medical Center Groningen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Boston Children's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospitals Cleveland Medical Center
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Martha AQ Curley, RN, PhD
Address 0 0
University of Pennsylvania
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
Per NHLBI policy, we will provide a deidentified dataset and all the data-related documentation necessary to utilize the study data (dictionary, calculated variables and standard operating procedures) to the NHLBI. We will submit this dataset to the NHLBI Data Repository managed by the BioLINCC (Biologic Specimen and Data Repository Information Coordinating Center).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
3 years after the final follow-up interview or 2 years after the primary paper has been published, whichever comes first.
Available to whom?
Subject to the approval of the (1) PROSpect Ancillary Study Committee, (2) PROSpect Executive Committee, and (3) National Heart, Lung, and Blood Institute (NHLBI).
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03896763