Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000464561
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effect of positioning in neonates with Congenital Diaphragmatic Hernia.
Scientific title
Using Electrical Impedance Tomography to Evaluate the Effect of Positioning in Neonates with Congenital Diaphragmatic Hernias
Secondary ID [1] 311685 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Diaphragmatic Hernia 333148 0
Condition category
Condition code
Human Genetics and Inherited Disorders 329846 329846 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Hours
Description of intervention(s) / exposure
In infants with Congenital Diaphragmatic hernia, we will observe the differences in lung ventilation in different positions.
The exposure will be the routine position changes, such as, supine, quarter turn from supine or side lie. Infants are normally positioned approximately every 6 hours. EIT and Physiological data will be collected after routine position changes - immediately, at 30 minutes, 1 hour, 2 hours and 6 hours after each position change. Recordings will continue for a total of 24 hours.
Participants will receive routine position changes regardless of their involvement in this study.
Intervention code [1] 328147 0
Early Detection / Screening
Comparator / control treatment
No control group - infants will be their own controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337612 0
Ventilation Distribution
Timepoint [1] 337612 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.
Primary outcome [2] 337613 0
End expiratory lung volume
Timepoint [2] 337613 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.
Primary outcome [3] 337614 0
Centre of Ventilation
Timepoint [3] 337614 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours
Secondary outcome [1] 432525 0
Heart rate,
Timepoint [1] 432525 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours
Secondary outcome [2] 433024 0
Respiratory rate,
Timepoint [2] 433024 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.
Secondary outcome [3] 433025 0
Oxygen saturation (SpO2),
Timepoint [3] 433025 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.
Secondary outcome [4] 433026 0
Inspired oxygen fraction (FiO2)
Timepoint [4] 433026 0
Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours

Eligibility
Key inclusion criteria
- Age less than or equal to 12 months
- CDH diagnosis
- Parents/ guardians given informed consent
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infants with associated anomalies that would directly affect postnatal outcome.
- Infants with associated disease or conditions compromising the cardiorespiratory system other than CDH.
- Infants with fragile skin conditions at risk of skin breakdown from the EIT belt.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The Mater Mothers Hospital receives on average, 30 CDH patients per year. As such, over a 4-month period, we expect a sample size of 10 infants.
Results will be presented as mean and standard deviation (SD) for the demographic and baseline clinical data. Generalised estimating equations will be used to determine differences and interactions between positions for each dependent variable. A p-value of < 0.05 will be considered statistically significant. All statistical analyses will be performed using SPSS (v26.0, Lead Technologies, Inc., Chicago, IL, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26241 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 42209 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315981 0
Hospital
Name [1] 315981 0
Mater Health
Country [1] 315981 0
Australia
Funding source category [2] 316110 0
University
Name [2] 316110 0
Australian Catholic University
Country [2] 316110 0
Australia
Primary sponsor type
Hospital
Name
Mater Health
Address
Country
Australia
Secondary sponsor category [1] 318122 0
University
Name [1] 318122 0
Australian Catholic University
Address [1] 318122 0
Country [1] 318122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314803 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 314803 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 314803 0
Australia
Date submitted for ethics approval [1] 314803 0
01/11/2023
Approval date [1] 314803 0
12/03/2024
Ethics approval number [1] 314803 0
HREC/MML/103705 (V5)
Ethics committee name [2] 314837 0
ACU Human Research Ethics Committee
Ethics committee address [2] 314837 0
https://staff.acu.edu.au/our_university/research/research-services/research-ethics
Ethics committee country [2] 314837 0
Australia
Date submitted for ethics approval [2] 314837 0
13/03/2024
Approval date [2] 314837 0
10/04/2024
Ethics approval number [2] 314837 0
2024-3336R

Summary
Brief summary
Congenital diaphragmatic hernia (CDH) is a condition requiring immediate medical and multidisciplinary management, including physiotherapy. Positioning is a commonly used physiotherapy technique supported by the literature. However, the extent of its improvement on the respiratory system is unknown due to the limitations of the measuring equipment. Current measuring tools lack the ability to detect regional changes in the lungs. Electrical impedance tomography (EIT) has shown to be safe and effective in other areas of the healthcare system but has not been used for infants with CDH. This study will use EIT to assess the effectiveness of positioning in infants with CDH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132782 0
Dr Judith Hough
Address 132782 0
Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014
Country 132782 0
Australia
Phone 132782 0
+61422404369
Fax 132782 0
Email 132782 0
judith.hough@acu.edu.au
Contact person for public queries
Name 132783 0
Judy Hough
Address 132783 0
Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014
Country 132783 0
Australia
Phone 132783 0
+61422404369
Fax 132783 0
Email 132783 0
Judith.hough@acu.edu.au
Contact person for scientific queries
Name 132784 0
Judith Hough
Address 132784 0
Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014
Country 132784 0
Australia
Phone 132784 0
+61422404369
Fax 132784 0
Email 132784 0
judith.hough@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The deidentified EIT and physiological data collected for each position for each baby will be shared as Excel spreadsheets.
When will data be available (start and end dates)?
Jan 2025 - no end date
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
ACU research bank - https://acuresearchbank.acu.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21817Study protocol    387431-(Uploaded-06-03-2024-17-52-50)-Study-related document.docx
21818Informed consent form    387431-(Uploaded-06-03-2024-17-51-14)-Study-related document.docx



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.