Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000290594
Ethics application status
Approved
Date submitted
13/02/2024
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
In neonates, how effective is lung ultrasonography in directing the use of Chest Physiotherapy (CPT) intervention when compared to the combination of Chest Radiograph (CXR) and auscultation?
Scientific title
In neonates, how effective is lung ultrasonography in directing the use of Chest Physiotherapy (CPT) intervention when compared to the combination of Chest Radiograph (CXR) and auscultation?
Secondary ID [1] 311532 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory distress syndrome 332885 0
lung disease 332887 0
Condition category
Condition code
Respiratory 329602 329602 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to evaluate the clinical effectiveness and feasibility of Lung Ultrasound (LUS) compared to routine CPT outcome measures of auscultation and CXR, in guiding decision-making around the use of CPT in neonates. Neonates will be considered for study eligibility as they are admitted to the Mater NICU. Recruited neonates will be consecutively enrolled over a 6-month period, accruing a minimum of 20 episodes. To investigate CPT for critically ill neonates, only participants identified as able to undergo CPT assessment along with having the possibility of re-assessment will be included. Further, as CPT plays a pivotal role in many of the neonates in the NICU and the possibility for multiple data collection episodes on a single participant, it is expected that the minimum episodes will be met to conduct a pilot study. Participants will undergo a routine assessment on admission by a trained neonatal physiotherapist using CXR, auscultation and evaluation of medical records. The assessment will be used to determine participant diagnosis and study eligibility. The physiotherapist will document the date and time that the participant underwent their CXR and what treatment they have received. At this stage, a CPT intervention plan will be determined.
Participants will then undergo a LUS examination by an examiner blinded to the original assessment findings and diagnosis. This will be an efficient process, with participants examined in the position they present in to avoid any increased handling. Up to six lung regions will be assessed with a 10MHz linear probe, as outlined in Brat et al. (2015). These regions may include upper and lower quadrants of the anterior and posterior lung, and/ or the lateral quadrants of each hemithorax, depending on the position of the neonate at the time of assessment. LUS diagnosis and findings will be shared with the physiotherapist who provided the initial assessment and a re-evaluation of intended treatment will occur. If a change to treatment intervention is made, this will be undertaken by the initial, assessing physiotherapist.
It is anticipated the LUS will take less than 10 minutes to complete and will be undertaken in whatever position the neonate presents in, meaning they will not be moved, or their position changed, in excess of their usual care. The LUS will occur during the neonate’s planned care time, thereby minimising any additional disruption or stress to the neonate. LUS scans will be undertaken by an advanced practice neonatal physiotherapist experienced in the management and handling of preterm and term born neonates. Where a neonate is deemed clinically unwell by the physiotherapist undertaking the LUS, discussion with the neonatologist will occur to ensure it is safe for the assessment to occur. As usual practice involves the assessment of all neonates by a physiotherapist in the NICU, regardless of gestation or birth weight, no limitations based on participant age or size will be imposed in this study.
If a previously unidentified lung abnormality is found (e.g., pneumothorax), the neonatologist will be informed to ensure optimal treatment. Also, the time interference of an extra LUS measurement will be negated through prioritising emergency treatment.


Intervention code [1] 328083 0
Diagnosis / Prognosis
Comparator / control treatment
All enrolled infants in this study will act as their own control. Infants will undergo a routine CPT assessment using CXR, auscultation and evaluation of medical records. Auscultation will occur in the position that the infant is in at the time. A provisional diagnosis and treatment plan will then be established. This treatment plan will reflect the control arm against which the addition of LUS assessment findings will be compared.

The comparator in this study will be the addition of LUS findings to the routine CPT assessment, to compare whether the additional LUS findings change the physiotherapist's diagnosis and treatment plan. The LUS will be performed immediately after the control phase (CPT assessment using CXR, auscultation and medical records review, including the formulation of diagnosis and treatment plan based on these findings). The LUS will be undertaken in the same position that the auscultation was performed (ie. the position the infant was in prior to the control taking place). The physiotherapist will be given the LUS findings and any changes to the diagnosis/ treatment plan documented.
Control group
Active

Outcomes
Primary outcome [1] 337390 0
Any change in Chest Physiotherapy treatment administered
Timepoint [1] 337390 0
At completion of both routine and lung ultrasound assessments
Primary outcome [2] 337532 0
Level of concordance between a clinical diagnosis made using LUS and a diagnosis using the combination of CXR and auscultation alone
Timepoint [2] 337532 0
At completion of both routine and lung ultrasound assessments
Primary outcome [3] 337533 0
Feasibility of implementing LUS as a CPT outcome measure in neonates
Timepoint [3] 337533 0
At completion of both routine and lung ultrasound assessments
Secondary outcome [1] 431651 0
physiotherapist confidence level in determining a diagnosis/ treatment intervention using routine assessment (CXR and auscultation) findings
Timepoint [1] 431651 0
At completion of routine assessment
Secondary outcome [2] 432238 0
physiotherapist confidence level in determining a diagnosis/ treatment intervention using LUS assessment findings
Timepoint [2] 432238 0
At completion of LUS assessment.

Eligibility
Key inclusion criteria
Neonates who:
• Are admitted to the NICU.
• Require mechanically ventilated.
• Are identified as meeting criteria for physiotherapy assessment.
• Have had a CXR in the previous 24 hours
Additionally, the parent/guardian must:
o Have signed the consent form.
o Be competent in understanding what the process will involve, assuring informed consent is obtained.
Minimum age
No limit
Maximum age
4 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• LUS not possible e.g. due to subcutaneous emphysema, dressings, wounds or skin integrity.
• Expected discharge or back transfer <24 hours.
• A plan for redirection of care.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26180 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 42051 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315828 0
Hospital
Name [1] 315828 0
Mater Mother's Hospital
Country [1] 315828 0
Australia
Primary sponsor type
Hospital
Name
Mater Mother's Hospital
Address
Country
Australia
Secondary sponsor category [1] 317956 0
University
Name [1] 317956 0
Australian Catholic University
Address [1] 317956 0
Country [1] 317956 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314684 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 314684 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 314684 0
Australia
Date submitted for ethics approval [1] 314684 0
09/11/2023
Approval date [1] 314684 0
01/02/2024
Ethics approval number [1] 314684 0

Summary
Brief summary
The primary purpose of this study is to evaluate the clinical effectiveness of LUS compared to routine chest physiotherapy outcome measures in determining the need for and effect of physiotherapy on neonates. This will be done by comparing whether LUS is better at guiding CPT treatment than looking at the lungs with CXR and listening to the lungs using a stethoscope. Results may help us improve how CPT is delivered to babies in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132390 0
Dr Judith Hough
Address 132390 0
School of Allied Health, Australian Catholic University, Saint John Paul II Building (Building 212, Level 1) Brisbane Campus, 1100 Nudgee Road, Banyo, QLD 4014 PO Box 456, Virginia, QLD 4014
Country 132390 0
Australia
Phone 132390 0
+61 0422404369
Fax 132390 0
Email 132390 0
[email protected]
Contact person for public queries
Name 132391 0
Judith Hough
Address 132391 0
School of Allied Health, Australian Catholic University, Saint John Paul II Building (Building 212, Level 1) Brisbane Campus, 1100 Nudgee Road, Banyo, QLD 4014 PO Box 456, Virginia, QLD 4014
Country 132391 0
Australia
Phone 132391 0
+61 0422404369
Fax 132391 0
Email 132391 0
[email protected]
Contact person for scientific queries
Name 132392 0
Judith Hough
Address 132392 0
School of Allied Health, Australian Catholic University, Saint John Paul II Building (Building 212, Level 1) Brisbane Campus, 1100 Nudgee Road, Banyo, QLD 4014 PO Box 456, Virginia, QLD 4014
Country 132392 0
Australia
Phone 132392 0
+61 0422404369
Fax 132392 0
Email 132392 0
[email protected]

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.