ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Congenital Diaphragmatic Hernia

Condition category

Condition code

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Early Detection / Screening

Comparator / control treatment

No control group - infants will be their own controls.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Ventilation Distribution

Timepoint [1]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.

Primary outcome [2]

End expiratory lung volume

Timepoint [2]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.

Primary outcome [3]

Centre of Ventilation

Timepoint [3]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours

Secondary outcome [1]

Heart rate,

Timepoint [1]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours

Secondary outcome [2]

Respiratory rate,

Timepoint [2]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.

Secondary outcome [3]

Oxygen saturation (SpO2),

Timepoint [3]

Data will be analysed after routine position changes immediately, at 30 minutes, 1 hour, 2 hours and 6 hours.

Secondary outcome [4]

Inspired oxygen fraction (FiO2)

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mater Health

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

Australian Catholic University

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

Mater Health

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Australian Catholic University

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee

Ethics committee address [1]

http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2023

Approval date [1]

12/03/2024

Ethics approval number [1]

HREC/MML/103705 (V5)

Ethics committee name [2]

ACU Human Research Ethics Committee

Ethics committee address [2]

https://staff.acu.edu.au/our_university/research/research-services/research-ethics

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

13/03/2024

Approval date [2]

10/04/2024

Ethics approval number [2]

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

Dr Judith Hough

Address

Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014

Country

Australia

Phone

+61422404369

Fax

[email protected]

Contact person for public queries

Name

Judy Hough

Address

Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014

Country

Australia

Phone

+61422404369

Fax

[email protected]

Contact person for scientific queries

Name

Judith Hough

Address

Australian Catholic University, 1100 Nudgee Rd, Banyo, Queensland 4014

Country

Australia

Phone

+61422404369

Fax

[email protected]

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.	Type	Citation	Link	Email	Other Details	Attachment
21817	Study protocol					387431-(Uploaded-06-03-2024-17-52-50)-Study-related document.docx
21818	Informed 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.

Trial Review

Documents added manually

Documents added automatically