search
Back to results

PROSpect: Prone and Oscillation Pediatric Clinical Trial

Primary Purpose

Acute Respiratory Distress Syndrome in Children

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Either supine or prone positioning and either CMV or HFOV
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome in Children focused on measuring Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, child, pediatric intensive care unit

Eligibility Criteria

2 Weeks - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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
  • 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 either prone positioning or any high-frequency mode of MV with current illness (Up to 4 hours of prone positioning and/or any mode of high-frequency mode of MV is allowed as long as the therapies are off for least 4 hours prior to the subject meeting oxygenation criteria.)
  • 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

Sites / Locations

  • Children's of Alabama
  • Arkansas Children's Hospital
  • Children's Hospital Orange County
  • Stanford Children's Health
  • UCSF Benioff Children's
  • Connecticut Children's Medical Center
  • Yale University
  • Kapiolani Medical Center for Women and Children
  • Ann & Robert Lurie Children's Hospital of Chicago
  • Riley Hospital for Children at IU Health
  • University of Iowa Stead Family Chlldren's Hospital
  • Norton Children's Hospital
  • Bloomberg Children's Center, Johns Hopkins University
  • CS Mott Children's Hospital
  • Children's Hospital and Medical Center
  • University of New Mexico Children's Hospital
  • The Children's Hospital of Montefiore
  • Cohen Children's Medical Center
  • Duke Children's Hospital
  • Children's Hospital at Oklahoma University Medical Center
  • Penn State Children's Hospital
  • Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • LeBonheur Children's Hospital
  • Medical City Dallas
  • Children's Health Dallas
  • Children's Hospital of San Antonio
  • Seattle Children's Hospital
  • Children's Hospital of Wisconsin
  • Queensland Children's Hospital
  • Perth Children's Hospital
  • Children's Hospital at Westmead
  • Sabara Hospital Infantil
  • Centre Hospitalier Universitaire Sainte Justine
  • Guangzhou Women & Children's Hospital (Newtown)
  • Guangzhou Women & Children's Hospital (Yuexiu)
  • Rainbow Children's Hospital
  • Hadassah Medical Center
  • Policlinico S. Orsola-Malpighi University Hospital
  • Meyer Children's Hospital
  • Instituto Giannina Gasilini
  • Bambino Gesu Children's Hospital (Area Rossa Unit)
  • Bambino Gesu Children's Hospital
  • University of Malaysia Medical Center
  • University Medical Center Groningen
  • Starship Children's Hospital
  • Cruces University Hospital
  • King Chulalongkorn Memorial Hospital
  • Faculty of Medicine Siriraj Hospital, Mahidol University
  • Faculty of Medicine Ramathibodi Hospital
  • Shaikh Khalifa Medical City
  • Birmingham Children's Hospital
  • University Hospital Leicester NHS Trust
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Supine / CMV

Prone / CMV

Supine / HVOF

Prone / HFOV

Arm Description

Supine positioning and conventional mechanical ventilation

Prone positioning and conventional mechanical ventilation

Supine positioning and high-frequency oscillatory ventilation

Prone positioning and high-frequency oscillatory ventilation

Outcomes

Primary Outcome Measures

Ventilator-free Days (VFD)
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.

Secondary Outcome Measures

Nonpulmonary organ failure-free days (OFFD)
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.

Full Information

First Posted
October 22, 2018
Last Updated
September 6, 2023
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University Medical Center Groningen, Boston Children's Hospital, University Hospitals Cleveland Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03896763
Brief Title
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Official Title
PROSpect: Prone and Oscillation Pediatric Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University Medical Center Groningen, Boston Children's Hospital, University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).
Detailed Description
PROSpect is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV). About 60 pediatric intensive care units (PICUs), two thirds U.S. and one third international, with at least 5 years of experience with prone positioning and HFOV in the care of pediatric patients with severe Pediatric Acute Respiratory Distress Syndrome (PARDS), that can provide back-up extracorporeal membrane oxygenation (ECMO) support, are participating. Eligible consecutive subjects with high moderate-severe PARDS will be randomized to one of four groups: supine/CMV, prone/CMV, supine/HFOV, prone/HFOV. Subjects who fail their assigned positional and/or ventilation therapy for either persistent hypoxia or hypercapnia may receive the reciprocal therapy while being considered for ECMO cannulation. Our primary outcome is ventilator-free days (VFD) through day 28, where non-survivors receive zero VFD. We hypothesize that children with severe PARDS treated with either prone positioning or HFOV will demonstrate ≥ 2 more VFD. Our secondary outcome is nonpulmonary organ failure-free days. We will also explore the interaction effects of prone positioning with HFOV on VFDs and also investigate the impact of these interventions on 90-day in-hospital mortality and, among survivors, the duration of mechanical ventilation, PICU and hospital length of stay, and the trajectory of post-PICU functional status and health-related quality of life (HRQL). Up to 800 subjects with severe PARDS will be randomized, stratified by age group and direct/indirect lung injury. Adaptive randomization will first occur after 300 patients are randomized and have been followed for 28 days, and every 100 patients thereafter. At these randomization update analyses, new allocation probabilities will be computed based on ongoing intention-to-treat trial results, increasing allocation to well performing arms and decreasing allocation to poorly performing arms. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol received for primary, secondary and exploratory analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome in Children
Keywords
Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, child, pediatric intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Two-by-two factorial, response-adaptive, randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supine / CMV
Arm Type
Experimental
Arm Description
Supine positioning and conventional mechanical ventilation
Arm Title
Prone / CMV
Arm Type
Experimental
Arm Description
Prone positioning and conventional mechanical ventilation
Arm Title
Supine / HVOF
Arm Type
Experimental
Arm Description
Supine positioning and high-frequency oscillatory ventilation
Arm Title
Prone / HFOV
Arm Type
Experimental
Arm Description
Prone positioning and high-frequency oscillatory ventilation
Intervention Type
Other
Intervention Name(s)
Either supine or prone positioning and either CMV or HFOV
Other Intervention Name(s)
Supine positioning, Prone positioing, Conventional mechanical ventilation (CMV), High frequency oscillatory ventilation (HFOV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator-free Days (VFD)
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Nonpulmonary organ failure-free days (OFFD)
Description
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.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Interaction effects of prone positioning with HFOV on VFDs - number of ventilator-free days
Description
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.
Time Frame
28 days
Title
90-day in-hospital mortality
Description
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.
Time Frame
90 days
Title
Duration of mechanical ventilation (among survivors)
Description
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).
Time Frame
28 days, 90 days
Title
PICU and hospital length of stay (among survivors)
Description
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).
Time Frame
90 days
Title
Post PICU discharge functional status
Description
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.
Time Frame
1, 3, 6, 12 months post PICU discharge
Title
Post PICU discharge health-related quality of life (HRQL)
Description
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.
Time Frame
1, 3, 6, 12 months post PICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha AQ Curley, RN, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ira M. Cheifetz, MD
Organizational Affiliation
UH Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin CJ Kneyber, MD, PhD
Organizational Affiliation
Beatrix Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wypij, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Children's Health
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Benioff Children's
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Ann & Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Stead Family Chlldren's Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Bloomberg Children's Center, Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
CS Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Hospital and Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of New Mexico Children's Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
The Children's Hospital of Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Cohen Children's Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Duke Children's Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Children's Hospital at Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19014
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Children's Health Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6840
Country
Australia
Facility Name
Children's Hospital at Westmead
City
Sydney
Country
Australia
Facility Name
Sabara Hospital Infantil
City
Sao Paulo
Country
Brazil
Facility Name
Centre Hospitalier Universitaire Sainte Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Facility Name
Guangzhou Women & Children's Hospital (Newtown)
City
Guangzhou
State/Province
Guangzhou
Country
China
Facility Name
Guangzhou Women & Children's Hospital (Yuexiu)
City
Guangzhou
Country
China
Facility Name
Rainbow Children's Hospital
City
Hyderabad
Country
India
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Policlinico S. Orsola-Malpighi University Hospital
City
Bologna
Country
Italy
Facility Name
Meyer Children's Hospital
City
Florence
Country
Italy
Facility Name
Instituto Giannina Gasilini
City
Genova
Country
Italy
Facility Name
Bambino Gesu Children's Hospital (Area Rossa Unit)
City
Rome
Country
Italy
Facility Name
Bambino Gesu Children's Hospital
City
Rome
Country
Italy
Facility Name
University of Malaysia Medical Center
City
Kuala Lumpur
Country
Malaysia
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Facility Name
Cruces University Hospital
City
Barakaldo
Country
Spain
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Shaikh Khalifa Medical City
City
Abu Dhabi
Country
United Arab Emirates
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
UK
Country
United Kingdom
Facility Name
University Hospital Leicester NHS Trust
City
Leicester
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
3 years after the final follow-up interview or 2 years after the primary paper has been published, whichever comes first.
IPD Sharing Access Criteria
Subject to the approval of the (1) PROSpect Ancillary Study Committee, (2) PROSpect Executive Committee, and (3) National Heart, Lung, and Blood Institute (NHLBI).
Links:
URL
http://www.prospect-network.org/
Description
Study Website

Learn more about this trial

PROSpect: Prone and Oscillation Pediatric Clinical Trial

We'll reach out to this number within 24 hrs