Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000292572
Ethics application status
Approved
Date submitted
14/02/2024
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability of lung ultrasound interpretation by physiotherapists in premature infants
Scientific title
Investigating inter-rater reliability for the use of lung ultrasound by physiotherapists in premature infants with Respiratory Distress Syndrome
Secondary ID [1] 307449 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory distress syndrome 326823 0
premature infant 326824 0
Condition category
Condition code
Respiratory 324039 324039 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 329837 329837 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a retrospective analysis of Lung Ultrasound (LUS) scans collected from preterm infants as part of a non-randomised, exploratory proof of concept study (Mater HREC Project 56566) investigating the effect of nebulised surfactant (AeroFact) on lung aeration and regional ventilation distribution (Electrical impedance tomography, thoracic breath sensor and LUS measurements of neonates with respiratory distress syndrome during surfactant administration: Mater HREC Project 56566). LUS scans being analysed were originally collected commencing in March 2021 and recruitment is ongoing. The study setting is Mater Mother’s Hospital Neonatal Critical Care Unit (NCCU) and Physiotherapy Department, South Brisbane, Queensland Australia. Anticipated completion on data collection is December 2023.. Scans previously collected by a neonatologist in the Aerofact study will have been de-identified with the infant’s study identification at the time of collection. Two LUS scans will have been collected, prior to and within 4 hours following, administration of nebulised surfactant. The LUS will be independently assessed by three novice physiotherapist assessors who have been trained in analysing LUS and are blinded to the history of the infants from whom the scans were taken. The assessors will all be currently working in the neonatal nursery and scans will have been previously deidentified and saved securely on the ultrasound machine. Interpretation will be undertaken by all assessors using a pre-determined standardised LUS scoring tool. based on previous studies (Brat et al, 2015). Each LUS scan will consist of 6 separate regional lung images that will be scored individually and independently on a dedicated score sheet by each assessor. A score between 0-3 will be given for each regional lung image depending on the specific signs identified in the following order: 0 = normal lung aeration (presence of A lines only), 1 = interstitial lung pathology (multiple, well-spaced B lines), 2 = alveolar patterning (crowded or coalescent B lines, with or without consolidation adjacent to the pleura) or 3 = extensive consolidation (Brat et al, 2015). Additionally, any other pathology identified (pleural effusion or pneumothorax) will also be documented. Total scores will also be calculated for each LUS scan by adding each of the separate regional lung scores together, with total scores ranging from 0-18.
Intervention code [1] 323902 0
Diagnosis / Prognosis
Comparator / control treatment
LUS scans will be accessed and scored independently by a neonatologist trained in the delivery and interpretation of LUS using the same standardised scoring system. The neonatologist will represent the experienced assessor and reference standard for this study against which three physiotherapists assessors’ interpretation will be correlated.
Control group
Active

Outcomes
Primary outcome [1] 331831 0
Intra-class correlations will be undertaken for total LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [1] 331831 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Primary outcome [2] 337400 0
Intra-class correlations for Right upper anterior lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [2] 337400 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Primary outcome [3] 337605 0
Intra-class correlations for Right lateral lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [3] 337605 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Secondary outcome [1] 431680 0
Intra-class correlations for R lower anterior lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [1] 431680 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Secondary outcome [2] 432494 0
Intra-class correlations for Left upper anterior lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [2] 432494 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Secondary outcome [3] 432495 0
Intra-class correlations for Left lateral lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [3] 432495 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.
Secondary outcome [4] 432497 0
Intra-class correlations for Left lower anterior lung region LUS scores to determine level of agreement between 3 physiotherapists, and 1 neonatologist
Timepoint [4] 432497 0
Following independent scoring of retrospectively-accessed LUS scans by 3 physiotherapist assessors and 1 neonatologist assessor.

Eligibility
Key inclusion criteria
A neonatologist experienced in delivery and interpretation of LUS images in neonates and preterm infants and physiotherapy staff who have undergone LUS training and who work in the Mater NCCU.
This is a retrospective analysis of previously collected LUS scans and no direct patient contact will be undertaken as part of this study
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physiotherapy staff previously not trained in the interpretation of LUS

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26181 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 42053 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311718 0
Hospital
Name [1] 311718 0
Mater Mother's Hospital
Country [1] 311718 0
Australia
Funding source category [2] 315838 0
Hospital
Name [2] 315838 0
Betty McGrath Mater Hospital Foundation
Country [2] 315838 0
Australia
Primary sponsor type
Hospital
Name
Mater Mother's Hospital
Address
Country
Australia
Secondary sponsor category [1] 313178 0
None
Name [1] 313178 0
Address [1] 313178 0
Country [1] 313178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311169 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 311169 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 311169 0
Australia
Date submitted for ethics approval [1] 311169 0
16/12/2021
Approval date [1] 311169 0
19/07/2022
Ethics approval number [1] 311169 0

Summary
Brief summary
This research study aims to look at whether physiotherapists working in the Neonatal Intensive Care Unit (NICU) can identify changes in babies’ lungs to the same level as a neonatologist using Lung Ultrasound (LUS) scans. Physiotherapists working in the NICU may provide chest physiotherapy (CPT) to preterm babies to help treat certain respiratory pathologies. Not all preterm babies require CPT and currently physiotherapists use multiple assessment tools to identify appropriate babies in lieu of a single existing Gold Standard measurement tool. Current assessment tools have inherent challenges and are not considered clinimetrically robust. LUS has been suggested as a new physiotherapy assessment tool because of its high level of valid, reliable and feasible lung imaging, that can be performed in real-time by the bedside, without exposing babies to radiation. This project will investigate whether neonatal physiotherapists can reliably interpret LUS scans compared to an experienced neonatologist. Results may allow physiotherapists to use LUS as an assessment tool in the future to help more safely and correctly identify babies who may benefit from chest physiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120194 0
Ms Bronagh McAlinden
Address 120194 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101
Country 120194 0
Australia
Phone 120194 0
+61 0403652991
Fax 120194 0
Email 120194 0
bronagh.mcalinden@mater.org.au
Contact person for public queries
Name 120195 0
Bronagh McAlinden
Address 120195 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101
Country 120195 0
Australia
Phone 120195 0
+61 0403652991
Fax 120195 0
Email 120195 0
bronagh.mcalinden@mater.org.au
Contact person for scientific queries
Name 120196 0
Bronagh McAlinden
Address 120196 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane QLD 4101
Country 120196 0
Australia
Phone 120196 0
+61 0403652991
Fax 120196 0
Email 120196 0
bronagh.mcalinden@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.