- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896763
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sydney, Australia
- Children's Hospital at Westmead
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Queensland
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South Brisbane, Queensland, Australia
- Queensland Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6840
- Perth Children's Hospital
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Sao Paulo, Brazil
- Sabara Hospital Infantil
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Quebec
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Montréal, Quebec, Canada, H3T1C5
- Centre Hospitalier Universitaire Sainte Justine
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Guangzhou, China
- Guangzhou Women & Children's Hospital (Yuexiu)
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Guangzhou
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Guangzhou, Guangzhou, China
- Guangzhou Women & Children's Hospital (Newtown)
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Hyderabad, India
- Rainbow Children's Hospital
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Jerusalem, Israel
- Hadassah Medical Center
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Bologna, Italy
- Policlinico S. Orsola-Malpighi University Hospital
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Florence, Italy
- Meyer Children's Hospital
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Genova, Italy
- Instituto Giannina Gasilini
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Rome, Italy
- Bambino Gesù Children's Hospital
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Rome, Italy
- Bambino Gesu Children's Hospital (Area Rossa Unit)
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Kuala Lumpur, Malaysia
- University of Malaysia Medical Center
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Groningen, Netherlands
- University Medical Center Groningen
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Auckland, New Zealand
- Starship Children's Hospital
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Barakaldo, Spain
- Cruces University Hospital
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Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital
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Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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Bangkok, Thailand
- Faculty of Medicine Ramathibodi Hospital
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Abu Dhabi, United Arab Emirates
- Shaikh Khalifa Medical City
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Leicester, United Kingdom
- University Hospital Leicester NHS Trust
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Southampton, United Kingdom
- University Hospital Southampton NHS Foundation Trust
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UK
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Birmingham, UK, United Kingdom
- Birmingham Children's Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's of Alabama
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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California
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Orange, California, United States, 92868
- Children's Hospital Orange County
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Palo Alto, California, United States, 94304
- Stanford Children's Health
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San Francisco, California, United States, 94143
- UCSF Benioff Children's
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06510
- Yale University
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Kapiolani Medical Center for Women and Children
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert Lurie Children's Hospital of Chicago
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children at IU Health
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Stead Family Chlldren's Hospital
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Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Children's Hospital
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Maryland
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Baltimore, Maryland, United States, 21287
- Bloomberg Children's Center, Johns Hopkins University
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Michigan
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Ann Arbor, Michigan, United States, 48109
- CS Mott Children's Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198
- Children's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico Children's Hospital
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New York
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Bronx, New York, United States, 10467
- The Children's Hospital of Montefiore
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Queens, New York, United States, 11040
- Cohen Children's Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Children's Hospital at Oklahoma University Medical Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, United States, 19014
- Children's Hospital of Philadelphia
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, United States, 38103
- LeBonheur Children's Hospital
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Texas
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Dallas, Texas, United States, 75230
- Medical City Dallas
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Dallas, Texas, United States, 75235
- Children's Health Dallas
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San Antonio, Texas, United States, 78207
- Children's Hospital of San Antonio
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Supine / CMV
Supine positioning and conventional mechanical ventilation
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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.
Other Names:
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Experimental: Prone / CMV
Prone positioning and conventional mechanical ventilation
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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.
Other Names:
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Experimental: Supine / HVOF
Supine positioning and high-frequency oscillatory ventilation
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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.
Other Names:
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Experimental: Prone / HFOV
Prone positioning and high-frequency oscillatory ventilation
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Ventilator-free Days (VFD)
Time Frame: 28 days
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Our primary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more ventilator-free days.
We hypothesize that a superior treatment would improve VFD by at least 2 days, a clinically meaningful difference.
VFD is the number of days within 28 days that a patient is alive and free of mechanical ventilation.
Improvement in VFD will be considered within the context of patient safety; specifically, patients must also exhibit a similar safety profile.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nonpulmonary organ failure-free days (OFFD)
Time Frame: 28 days
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Our secondary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more more nonpulmonary organ failure-free days.
OFFD is the number of days within 28 days that a patient is alive and free of clinically significant non-pulmonary organ failure.
Nonpulmonary organ failure-free days will be calculated based on the clinically important nonpulmonary organ systems (neurologic, cardiovascular, renal and hematologic) using nonpulmonary PEdiatric Logistic Organ Dysfunction-2 (PELOD-20 scores.
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28 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interaction effects of prone positioning with HFOV on VFDs - number of ventilator-free days
Time Frame: 28 days
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The number of ventilator-free days (VFD) will be compared between children randomized to prone/CMV and supine/HFOV to those randomized to prone/HFOV.
VFD is the number of days within 28 days that a patient is alive and free of mechanical ventilation.
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28 days
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90-day in-hospital mortality
Time Frame: 90 days
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Deaths from all causes will be monitored through hospital discharge or day 90 (whichever occurs first).
The primary and secondary causes of death (as specified on the death certificate) will be recorded to allow us to probe the cause of death in PARDS.
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90 days
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Duration of mechanical ventilation (among survivors)
Time Frame: 28 days, 90 days
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Duration of mechanical ventilation provides a prospective evaluation of ventilator support independent of mortality.
The duration of mechanical ventilation is defined as the time from day 0 (intubation) to the first time the endotracheal tube is continuously absent for at least 24 hours.
For subjects with tracheostomies, duration of mechanical ventilation is defined as the time of initiation of assisted breathing to the first time positive pressure is <5 cm H2O (continuous or bi-level) for at least 24 hours.
Duration of mechanical ventilation will be considered to be 28 days for subjects still intubated on day 28, and will be calculated for subjects who survive to hospital discharge or day 90 (whichever occurs first).
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28 days, 90 days
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PICU and hospital length of stay (among survivors)
Time Frame: 90 days
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PICU length of stay (LOS) is defined as the time from day 0 (intubation) to the time of PICU discharge, while hospital LOS is defined as the time from day 0 to the time of hospital discharge.
PICU and hospital LOS will be considered to be 90 days for subjects still in the PICU/hospital on day 90, and will be calculated for subjects who survive to hospital discharge or day 90 (whichever occurs first).
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90 days
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Post PICU discharge functional status
Time Frame: 1, 3, 6, 12 months post PICU discharge
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Pre and post PICU functional status will be compared.
Functional status will be assessed using the Pediatric Cerebral Performance (PCPC), Pediatric Overall Performance Category (POPC) and Functional Status Scale (FSS) score.
The PCPC and POPC quantify short-term cognitive impairments and functional morbidity.
Scores range from 1 to 6 for both scales with 1: good, 2: mild disability, and 6: brain death.
The 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.
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1, 3, 6, 12 months post PICU discharge
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Post PICU discharge health-related quality of life (HRQL)
Time Frame: 1, 3, 6, 12 months post PICU discharge
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Pre and post PICU health-related quality of life will be compared using the PedsQL 4.0 Generic Core Scales and Infant Scales - Acute Version They are 23-item child self-report and parent proxy-report scales with four domains: physical functioning, emotional functioning, social functioning, and school functioning.
Scale ranges from 0 to 100, with higher scores indicating fewer problems.
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 PedsQL™ Multi-dimensional Fatigue Scale - Acute Version is an 18-item scale that encompasses three domains: General Fatigue, Sleep/Rest Fatigue and Cognitive Fatigue.
Higher scores indicate better HRQOL.
PedsQL Pediatric Pain Questionnaire is a generic pain instrument.
Subjects capable of self-reporting identify a point on a 100 mm line that best shows the worst pain they experienced in the past week.
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1, 3, 6, 12 months post PICU discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ira M. Cheifetz, MD, UH Rainbow Babies and Children's Hospital
- Principal Investigator: Martin CJ Kneyber, MD, PhD, Beatrix Children's Hospital
- Principal Investigator: David Wypij, PhD, Boston Children's Hospital
- Principal Investigator: Martha AQ Curley, RN, PhD, University of Pennsylvania
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831295
- 5UH3HL141736-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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