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Trial registered on ANZCTR
Registration number
ACTRN12623000903684
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
23/08/2023
Date last updated
29/02/2024
Date data sharing statement initially provided
23/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Calculation Of Lung Inflation in Neonates
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Scientific title
Validating the use of chest x-rays as measures of lung volume in neonates using computed tomography
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Secondary ID [1]
310316
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None
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Universal Trial Number (UTN)
U1111-1296-3076
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Trial acronym
COLIN Study
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Linked study record
Not Applicible
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Health condition
Health condition(s) or problem(s) studied:
neonate
331031
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Respiratory Diseases
331032
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Mechanical Ventilation
331033
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Computerised Tomography
331034
0
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Condition category
Condition code
Respiratory
327830
327830
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
This project aims to assess the relationship between the number of ribs seen on Chest Radiograph (CXR) and the lung volume and aeration measures on chest Computerised Tomography (CT) in ventilated neonates to evaluate the accuracy of using the CXR as a simple and convenient method of predicting lung volume and inflation in the clinical setting. CT images will be sourced from the Royal Children's Hospital (Melbourne) Medical Imaging Data based from 1 January 2011 to 1 September 2023.
Retrospective observational study of CT data of neonates <31 days of age (or <31 days corrected gestational age if born preterm) who meet study eligibility criteria. De-identified CT images will be segmented to calculate the left and right lung volume (cm3) and Hounsfeld Unit (aeration measure) value for each lung. The Scout CXR (Scout Topogram) will also be assessed using a standardised method to determine the rib number at the diaphragm of each lung. Absolute lung volume and aeration (Hounsfeld Unit value) will be compared to the rib level estimate of lung volume. Assessment of CT outcomes will be performed by at least 2 experienced independent assessors for each measure, who will be blinded to all assessor values. The same approach will be undertaken for CXR outcomes using a different team of assessors.
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Intervention code [1]
326696
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [1]
335681
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Timepoint [1]
335681
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Time Computerised Tomography scan was performed
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Secondary outcome [1]
425175
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The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during phase of respiratory cycle.
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Assessment method [1]
425175
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Timepoint [1]
425175
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Time Computerised Tomography scan was performed
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Secondary outcome [2]
425176
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The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during of type of respiratory support.
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Assessment method [2]
425176
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Timepoint [2]
425176
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Time Computerised Tomography scan was performed
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Secondary outcome [3]
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The distribution of left lung volume (ml/kg body weight) at each of the measured left diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [3]
425480
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Timepoint [3]
425480
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Time Computerised Tomography scan was performed
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Secondary outcome [4]
425481
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The distribution of right lung volume (ml/kg body weight) at each of the measured right diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [4]
425481
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Timepoint [4]
425481
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Time Computerised Tomography scan was performed
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Secondary outcome [5]
425483
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The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [5]
425483
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Timepoint [5]
425483
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Time Computerised Tomography scan was performed
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Secondary outcome [6]
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The Hounsfield Unit values (measure of aeration state) at each of the measured right diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [6]
425485
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Timepoint [6]
425485
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Time Computerised Tomography scan was performed
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Secondary outcome [7]
425486
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The Hounsfield Unit values (measure of aeration state) at each of the measured left diaphragm positions in the study cohort (6-11 ribs).
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Assessment method [7]
425486
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Timepoint [7]
425486
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Time Computerised Tomography scan was performed
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Secondary outcome [8]
425487
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The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during phase of respiratory cycle. .
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Assessment method [8]
425487
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Timepoint [8]
425487
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Time Computerised Tomography scan was performed
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Secondary outcome [9]
425488
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The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs) during of type of respiratory support.
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Assessment method [9]
425488
0
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Timepoint [9]
425488
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Time Computerised Tomography scan was performed
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Eligibility
Key inclusion criteria
Neonates will be eligible if they have had a CT chest within the first 31 days of life (corrected gestational age) at the Royal Children’s Hospital in Melbourne, Victoria.
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Minimum age
0
Days
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Maximum age
30
Days
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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
Neonates will be excluded if they meet the following criteria:
1. The CT scan is conducted after 31 days corrected gestational age.
2. The scout CXR has a cardiothoracic ratio above 0.6 indicating cardiomegaly and distortion of the thoracic structures.
3. The scout CXR shows significant lordosis or scoliosis which would distort accurate assessment of rib/diaphragm relationship.
4. A single ventricle is identified on the CT scan.
5. Participants suffer from congenital lung pathology including congenital diaphragmatic hernia, congenital pulmonary airway malformation (previously congenital cystic adenomatoid malformations), pulmonary sequestration, congenital lobar emphysema, bronchogenic cysts.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
The aim is to analyse up to 300 CT scans from neonates who meet the study eligibility criteria. This number is based on preliminary discussions with the Department of Radiology as to the availability of scans stored within the Departments Database since the onset of the Royal Children’s Hospital current electronic medical record system (2011 to current). A feasibility sample size of at least 200 CT scans was determined to ensure a robust number subjects for each of the potential rib values (6-11) for reasonable interpretation after consultation with a Statistician at the Centre of Epidemiology and Biostatistics Unit (Murdoch Children's Research Institute).
The relationship between the diaphragm position and the calculated CT lung volume will be analysed and represented through a descriptive analysis and the distribution of lung volumes will be represented using boxplots. The relationship between CT measures and diaphragm position will be further assessed using correlation and linear regression analysis if appropriate. Subgroup analysis following the same methodology and stratification will be completed of the demographic data, HU, indication for CT, diagnosis and ventilation phase of the scans. Data analysis will be performed in the R Statistical Software package.
In the pilot work, an initial 30 randomly selected CT scans were assessed by three investigators twice using the CT volume calculation methods to assess reliability and reproducibility of volume calculations. The degree of discrepancy between the individual measurements will be determined by calculating the intra-class correlation coefficients with a two-way random effect model. Inter and intra-investigator was high (>95%).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/08/2023
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Actual
4/09/2023
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Date of last participant enrolment
Anticipated
30/11/2023
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Actual
24/11/2023
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Date of last data collection
Anticipated
16/01/2024
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Actual
30/01/2024
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Sample size
Target
258
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Accrual to date
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Final
218
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
41052
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
314524
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Other
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Name [1]
314524
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Murdoch Childrens Research institute Neonatal Research Group
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Address [1]
314524
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Murdoch Childrens Research institute
50 Flemington Road
Parkville Victoria 3052
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Country [1]
314524
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Australia
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Primary sponsor type
Other
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Name
Murdoch Childrens Research institute
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Address
50 Flemington Road
Parkville Victoria 3052
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Country
Australia
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Secondary sponsor category [1]
316481
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None
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Name [1]
316481
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Address [1]
316481
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Country [1]
316481
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Other collaborator category [1]
282789
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Hospital
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Name [1]
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Royal Childrens Hospital
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Address [1]
282789
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50 Flemington Road
Parkville Victoria 3052
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Country [1]
282789
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Australia
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Other collaborator category [2]
282790
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University
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Name [2]
282790
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University of Melbourne
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Address [2]
282790
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Department of Paediatrics
50 Flemington Road
Parkville Victoria 3052
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Country [2]
282790
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313566
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The Royal Children’s Hospital (Melbourne) Human Research Ethics Committee
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Ethics committee address [1]
313566
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Department of Research Ethics and Governance The Royal Children’s Hospital 50 Flemington Road Parkville Victoria 3052
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Ethics committee country [1]
313566
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Australia
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Date submitted for ethics approval [1]
313566
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15/06/2023
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Approval date [1]
313566
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12/07/2023
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Ethics approval number [1]
313566
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99967/RCHM-2023
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Summary
Brief summary
Chest x-ray (CXR) are a simple and commonly used tool to assess the lungs of a neonate. Most neonates receiving assisted mechanical ventilation will have a CXR at some stage after starting treatment (many will have serial CXRs over time). Clinicians often use CXRs to help determine the impact of mechanical ventilation (use of a breathing machine to support diseased or sick lungs) on a patient’s lung. It is commonly taught that lung volume can be assessed through the number of posterior ribs seen above the diaphragm in a CXR (diaphragm position; the more ribs the larger the lung volume). This is commonly used in adults to assess for emphysematous changes, or hyperinflation, in chronic obstructive lung disease or asthma. Counting ribs on a CXR, as a mechanism of quickly assessing lung, volume is often recommended in neonatal ICU guidelines. Normal inflation of the lung is considered to be between a diaphragm position of the 8-9th posterior rib, with less than 7 ribs indicating underinflated lungs and over 10 ribs indicating overinflated lungs, although varying thresholds are used. Estimation of lung volume using diaphragm position assessment is also commonly used to titrate specific ventilation settings. Despite being used to guide clinically important decisions, there have been few studies that have assessed and analysed the relationship between the number of ribs above the diaphragm and lung volume. Those that have assessed this question, have either found no significant relationship,2 or have formulated a 3D structure of the lungs from multiple scans to accurately represent lung volume, a method which is not used in clinical practice. There is a need to determine whether this common practice (counting ribs on CXR) to guide important intensive care interventions is useful as a measure of lung volume in neonates. Computed Tomography (CT) is a gold standard measurement of lung aeration and volume. It provides detailed information regarding the aeration of the lungs (such as the absolute amount of lung tissue collapsed or overdistended) and can provide the value and measurements of lung volume in ml/kg for an individual. However, due to the associated increased radiation exposure, CT is not routinely performed in neonates. The aim of this retrospective observational study is therefore to evaluate the relationship between the number of the ribs above the diaphragm on a CXR and the lung volume and aeration as measured through a CT chest. This study will be completed through a retrospective analysis of neonatal chest CTs from a data bank at the Royal Children’s Hospital in Melbourne, Victoria. Lung volume and aeration measures will be derived from CT imaging and compared to diaphragm position on the scout CT image (which is the same as a CXR) performed at the start of every CT. The relationship between lung volume, lung aeration and diaphragm position will then be compared.
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Trial website
None
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Trial related presentations / publications
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Public notes
None
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Contacts
Principal investigator
Name
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Prof David Tingay
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Address
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Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052
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Country
128570
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Australia
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Phone
128570
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+61 03 93454023
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Fax
128570
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Email
128570
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[email protected]
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Contact person for public queries
Name
128571
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David Tingay
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Address
128571
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Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052
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Country
128571
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Australia
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Phone
128571
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+61 03 93454023
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Fax
128571
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Email
128571
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[email protected]
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Contact person for scientific queries
Name
128572
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David Tingay
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Address
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Neonatal Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052
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Country
128572
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Australia
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Phone
128572
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+61 03 93454023
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Fax
128572
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Email
128572
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification and primary publication
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When will data be available (start and end dates)?
Beginning 3 months and ending 7 years following main results publication
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Available to whom?
Researchers who provide a methodologically sound proposal, with approval by an independent review committee
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Available for what types of analyses?
Any scientific purpose to achieve the aims in the approved proposal
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
). Data requestors will need to sign a data access or material transfer agreement approved by Murdoch Childrens Research Institute.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19938
Study protocol
386378-(Uploaded-07-08-2023-14-24-28)-Study-related document.pdf
19939
Data dictionary
386378-(Uploaded-07-08-2023-15-31-36)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF