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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
Scientific title
Validating the use of chest x-rays as measures of lung volume in neonates using computed tomography
Secondary ID [1] 310316 0
None
Universal Trial Number (UTN)
U1111-1296-3076
Trial acronym
COLIN Study
Linked study record
Not Applicible

Health condition
Health condition(s) or problem(s) studied:
neonate 331031 0
Respiratory Diseases 331032 0
Mechanical Ventilation 331033 0
Computerised Tomography 331034 0
Condition category
Condition code
Respiratory 327830 327830 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 326696 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335681 0
The distribution of total lung volume (ml/kg body weight) at each of the measured diaphragm positions in the study cohort (6-11 ribs).
Timepoint [1] 335681 0
Time Computerised Tomography scan was performed
Secondary outcome [1] 425175 0
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.
Timepoint [1] 425175 0
Time Computerised Tomography scan was performed
Secondary outcome [2] 425176 0
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.
Timepoint [2] 425176 0
Time Computerised Tomography scan was performed
Secondary outcome [3] 425480 0
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).
Timepoint [3] 425480 0
Time Computerised Tomography scan was performed
Secondary outcome [4] 425481 0
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).
Timepoint [4] 425481 0
Time Computerised Tomography scan was performed
Secondary outcome [5] 425483 0
The Hounsfield Unit values (measure of aeration state) at each of the measured diaphragm positions in the study cohort (6-11 ribs).
Timepoint [5] 425483 0
Time Computerised Tomography scan was performed
Secondary outcome [6] 425485 0
The Hounsfield Unit values (measure of aeration state) at each of the measured right diaphragm positions in the study cohort (6-11 ribs).
Timepoint [6] 425485 0
Time Computerised Tomography scan was performed
Secondary outcome [7] 425486 0
The Hounsfield Unit values (measure of aeration state) at each of the measured left diaphragm positions in the study cohort (6-11 ribs).
Timepoint [7] 425486 0
Time Computerised Tomography scan was performed
Secondary outcome [8] 425487 0
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. .
Timepoint [8] 425487 0
Time Computerised Tomography scan was performed
Secondary outcome [9] 425488 0
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.
Timepoint [9] 425488 0
Time Computerised Tomography scan was performed

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.
Minimum age
0 Days
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
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%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
24/11/2023
Date of last data collection
Anticipated
16/01/2024
Actual
30/01/2024
Sample size
Target
258
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41052 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 314524 0
Other
Name [1] 314524 0
Murdoch Childrens Research institute Neonatal Research Group
Country [1] 314524 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research institute
Address
50 Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 316481 0
None
Name [1] 316481 0
Address [1] 316481 0
Country [1] 316481 0
Other collaborator category [1] 282789 0
Hospital
Name [1] 282789 0
Royal Childrens Hospital
Address [1] 282789 0
50 Flemington Road Parkville Victoria 3052
Country [1] 282789 0
Australia
Other collaborator category [2] 282790 0
University
Name [2] 282790 0
University of Melbourne
Address [2] 282790 0
Department of Paediatrics 50 Flemington Road Parkville Victoria 3052
Country [2] 282790 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313566 0
The Royal Children’s Hospital (Melbourne) Human Research Ethics Committee
Ethics committee address [1] 313566 0
Ethics committee country [1] 313566 0
Australia
Date submitted for ethics approval [1] 313566 0
15/06/2023
Approval date [1] 313566 0
12/07/2023
Ethics approval number [1] 313566 0
99967/RCHM-2023

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

Contacts
Principal investigator
Name 128570 0
Prof David Tingay
Address 128570 0
Neonatal Research Murdoch Childrens Research Institute 50 Flemington Road Parkville Victoria 3052
Country 128570 0
Australia
Phone 128570 0
+61 03 93454023
Fax 128570 0
Email 128570 0
[email protected]
Contact person for public queries
Name 128571 0
David Tingay
Address 128571 0
Neonatal Research Murdoch Childrens Research Institute 50 Flemington Road Parkville Victoria 3052
Country 128571 0
Australia
Phone 128571 0
+61 03 93454023
Fax 128571 0
Email 128571 0
[email protected]
Contact person for scientific queries
Name 128572 0
David Tingay
Address 128572 0
Neonatal Research Murdoch Childrens Research Institute 50 Flemington Road Parkville Victoria 3052
Country 128572 0
Australia
Phone 128572 0
+61 03 93454023
Fax 128572 0
Email 128572 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal, with approval by an independent review committee

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification and primary publication

What types of analyses could be done with individual participant data?
• Any scientific purpose to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 7 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19938Study protocol    Study-related document.pdf
19939Data dictionary    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.