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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06166706
Registration number
NCT06166706
Ethics application status
Date submitted
4/12/2023
Date registered
12/12/2023
Titles & IDs
Public title
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
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Scientific title
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
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Secondary ID [1]
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C1_bigapple_V1.2
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Universal Trial Number (UTN)
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Trial acronym
BIG APPLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation Complication
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Pediatric ALL
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Pulmonary Complication
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Perioperative/Postoperative Complications
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Condition category
Condition code
Surgery
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Other surgery
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Neonates - neonates up to 44 weeks postmenstrual age or up to 60 weeks post menstrual age if born premature (GA \<37 weeks) undergoing general anaesthesia with mechanical ventilation.
No intervention will be administered.
Infants - Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
Toddlers - Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
Preschool - Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
School-aged and adolescents - School aged children and adolescents of 6 to17 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of postoperative pulmonary complications
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Assessment method [1]
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incidence of postoperative pulmonary complications (PPCs) in the first five postoperative days. Definition of postoperative pulmonary complications:
• Invasive mechanical ventilation after discharge from the operating room.
* respiratory failure defined as: PaO2 \< 8 kPa or SpO2\< 90% despite oxygen therapy, with a need for non-invasive ventilation (NIV)
* unplanned oxygen therapy, including humidified high flow nasal oxygen (oxygen administered due to PaO2\< 8 kPa or SpO2\< 90% in room air
* need for bronchodilators postoperatively in the PACU or at the ward;
* pneumonia;
* ARDS;
* pneumothorax.
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Timepoint [1]
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follow-up up to day 5 postoperative
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Secondary outcome [1]
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type of ventilation mode
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Assessment method [1]
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what type of ventilation mode is chosen
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Timepoint [1]
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15 minutes after incision
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Secondary outcome [2]
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Tidal volume (Vt)
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Assessment method [2]
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average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.
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Timepoint [2]
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15 minutes after incision
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Secondary outcome [3]
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postoperative end-expiratory pressure (PEEP)
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Assessment method [3]
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level of PEEP
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Timepoint [3]
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15 minutes after incision
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Secondary outcome [4]
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Peak inspiratory pressure or plateau pressure
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Assessment method [4]
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Measured peak inspiratory or plateau pressure
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Timepoint [4]
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15 minutes after incision
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Secondary outcome [5]
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Level of pressure support above PEEP
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Assessment method [5]
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Level of pressure support above PEEP, only in spontaneously breathing patients
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Timepoint [5]
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15 minutes after incision
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Secondary outcome [6]
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Inspiratory fraction of oxygen (FiO2)
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Assessment method [6]
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measured inspiratory O2 fraction
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Timepoint [6]
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15 minutes after incision
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Secondary outcome [7]
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I:E ratio
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Assessment method [7]
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I:E ratio or inspiratory time, measured in sec
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Timepoint [7]
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15 minutes after incision
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Secondary outcome [8]
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Saturation (SpO2)
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Assessment method [8]
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measured SpO2
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Timepoint [8]
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15 mintues after incision
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Secondary outcome [9]
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end-tidal carbondioxide (etCO2)
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Assessment method [9]
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measured etCO2
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Timepoint [9]
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15 minutes after incision
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Secondary outcome [10]
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Respiratory rate
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Assessment method [10]
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set and actual respiratory rate
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Timepoint [10]
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15 minutes after incision
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Secondary outcome [11]
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Compliance (Crs)
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Assessment method [11]
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calculated compliance
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Timepoint [11]
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15 minutes after incision
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Secondary outcome [12]
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Driving pressure
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Assessment method [12]
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calculated driving pressure
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Timepoint [12]
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15 mintues after incision
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Secondary outcome [13]
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Mechanical power
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Assessment method [13]
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calculated mechanical power
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Timepoint [13]
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15 minutes after incision
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Secondary outcome [14]
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Intraoperative complications
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Assessment method [14]
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intraoperative complications are defined as: oxygen desaturation (SpO2 \< 90%), hypercapnia (etCO2 \> 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.
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Timepoint [14]
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during surgery
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Secondary outcome [15]
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Length of hospital stay
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Assessment method [15]
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total duration of stay in hospital, measured in days
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Timepoint [15]
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follow-up up to day 5 postoperative
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Secondary outcome [16]
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Admittance to PICU or neonatal intensive care unit (NICU)
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Assessment method [16]
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planned and unplanned admission to PICU or NICU
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Timepoint [16]
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follow-up up to day 5 postoperative
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Eligibility
Key inclusion criteria
* aged = 16 years;
* undergoing general anesthesia
* airway management with tube or LMA; and
* connected to mechanical ventilator . minimum duration of procedure: 15 minutes
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Minimum age
No limit
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* patients undergoing surgical procedures involving extra-corporal circulation;
* patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation;
* sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and
* (rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/05/2025
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
Country [1]
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Italy
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State/province [1]
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Genoa
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Country [2]
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Netherlands
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State/province [2]
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Please Select
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Country [3]
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Switzerland
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State/province [3]
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Bern
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Funding & Sponsors
Primary sponsor type
Other
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Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.
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Trial website
https://clinicaltrials.gov/study/NCT06166706
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marcus Schultz, Prof
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Address
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Amsterdam UMC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jorinde Polderman, MD, PhD
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Address
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Country
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Phone
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+31205669111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Authors of the publication will be team members of the steering committee who contributed to the design, conduct or analysis of the study and who approved of the final version of the manuscript, plus the BIG APPLE investigators. All participating investigators will be collaborator of this group and will be included on all publications from the BIG APPLE database. Local PIs agree not to individually publish or present the results they obtain from the participation in this multicenter study before the publication of the main results of the study. According to FAIR data principles, the pooled dataset will be available for all members of the BIG APPLE collaboration on request for secondary analyses after judgement and approval of scientific quality and validity by the Steering Committee.
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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/NCT06166706