ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000092594p

Ethics application status

Not yet submitted

Date submitted

21/12/2023

Date registered

1/02/2024

Date last updated

14/07/2024

Date data sharing statement initially provided

1/02/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The Neonatal Ventilation using Tomography (NEOVENT) Study

Scientific title

The Neonatal Ventilation registry using Tomography (NEOVENT) Study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1301-9600

Trial acronym

NEOVENT Study

Linked study record

Health condition

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

Neonatal Respiratory Failure

Respiratory Support

Prematurity

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Respiratory

Normal development and function of the respiratory system

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

15

Target follow-up type

Weeks

Description of intervention(s) / exposure

Neonates born between 22+0 weeks’ gestation and term gestation admitted to a participating centre needing assisted respiratory support for any cause of respiratory failure in whom prospective parental informed consent can be obtained will be considered eligible. Measurements of lung function will be made using electrical impedance tomography (EIT) at different times in their neonatal intensive care journey. These measurements will be made over 30-60 min of stable respiratory support after any change in mode or type of respiratory support and during procedures and treatments likely to alter respiratory function (surfactant therapy, extubation and intubation). For neonates requiring an anticipated NICU course of 4 or more weeks, weekly assessment of lung function will be made. The maximum duration of observation (EIT imaging) will be until birth or 36 weeks corrected post-menstrual age whichever is longest.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Gravity dependent centre of ventilation

Timepoint [1]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [1]

Center of ventilation along the right-left plane of the lung

Timepoint [1]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [2]

Percentage of the lung that is not engaged in tidal ventilation (termed silent spaces)

Timepoint [2]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [3]

Percentage of total delivered tidal volume (VT) occurring within 6 (3 left lung and 3 right lung) equally weighted (by estimated lung size) gravity-dependent regions of interest within the lung

Timepoint [3]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [4]

Relative aeration state of the lung

Timepoint [4]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [5]

Relative gas flow within the lung

Timepoint [5]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [6]

Modified Oxygenation index

Timepoint [6]

During or within 30 min of pre-defined respiratory interventions or events that occur from birth until discharge or 36 weeks corrected post menstrual age.

Secondary outcome [7]

Bronchopulmonary Dysplasia grade

Timepoint [7]

36 weeks corrected post-mensural age

Secondary outcome [8]

Death

Timepoint [8]

Anytime during NICU admission

Secondary outcome [9]

Maximum Level of respiratory support during primary NICU admission

Timepoint [9]

Anytime during NICU admission

Secondary outcome [10]

Pneumothorax

Timepoint [10]

Anytime during NICU admission

Eligibility

Key inclusion criteria

Neonates will be considered eligible for the study if they meet all of the following criteria:
1. Born between 22+0 weeks’ gestation and term gestation.
2. Receiving assisted respiratory support for any cause of respiratory failure at a participating NICU.
3. Parents or guardians able to provide written informed consent.

Minimum age

0 Hours

Maximum age

14 Weeks

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Participants meeting any of the following criteria will be excluded from this study:
1. Any neonate whom the clinical team request we do not study.
2. Neonates in whom the placement of EIT belt at the standard position (nipple level) would interfere with clinical care, such as wound dressings, surgical sites or chest drains.
3. Neonates with known or suspected skin disease (e.g. Epidermolysis Bullosa) or at risk of breeches to skin integrity from wearable monitoring devices.
4. Families from which informed written consent cannot be obtained.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

This study aims to enrol as many neonates as practice over the 5-year study period (convenience sample). Based on admission data for all Level 6 NICU in Melbourne for 2021-22 (750 infants per annum) this is likely to represent a minimum of 250-350 infants assuming a <10% recruitment rate and a maximum of 1000 infants (30% recruitment rate). From this sample population different analysis for specific study aims will be undertaken.

Continuous data will be analysed either with descriptive statistics or with a mixed-effects linear regression model, with robust standard error and cluster analysis to adjust for multiple breaths from each neonate.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

12/08/2024

Actual

Date of last participant enrolment

Anticipated

28/02/2029

Actual

Date of last data collection

Anticipated

31/05/2029

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

3168 - Clayton

Recruitment postcode(s) [4]

3021 - St Albans

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St,Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Murdoch Children's Research Institute

Address

50 Flemington Rd Parkville, Victoria 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

50 Flemington Rd Parkville, Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2024

Approval date [1]

19/06/2024

Ethics approval number [1]

HREC/105075/RCHM-2024

Summary

Brief summary

Respiratory disease is the most common reason for admission to a NICU. Unfortunately, our understanding of how many respiratory therapies used in the NICU help babies lungs is poor. Broadly, we will create a large registry of lung function data during common NICU respiratory events and diseases. By doing so we will be able to address some of the uncertainties in clinical care for babies born with respiratory failure, specifically how best to determine optimal levels of respiratory support and how to guide common respiratory interventions such as extubation and surfactant therapy. We hypothesise that by generating a greater understanding of the relationship between a baby's lung disease and NICU respiratory care we will provide the tools to allow clinicians to improve respiratory care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Tingay

Address

Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052

Country

Australia

Phone

+61 393454023

Fax

Email

[email protected]

Contact person for public queries

Name

David Tingay

Address

Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052

Country

Australia

Phone

+61 393454023

Fax

Email

[email protected]

Contact person for scientific queries

Name

David Tingay

Address

Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052

Country

Australia

Phone

+61 393454023

Fax

Email

[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?

Individual participant data collected during the study, after de-identification,
and study protocols and statistical analysis code are available beginning 3 months and ending
23 years following article publication to researchers who provide a methodological sound
proposal, with approval by an independent review committee (“learned intermediatry”)
identified for purpose. Data is available for analysis to achieve aims in the approved proposal.
Proposals should be directed to [email protected]; to gain access, data requestors will need to sign a data access or material transfer agreement approved by the Murdoch Children’s Research Institute.

When will data be available (start and end dates)?

Beginning 3 months and ending 23 years following article publication

Available to whom?

Researchers who provide a methodological sound proposal

Available for what types of analyses?

All available patient data, imaging files and imaging (EIT) codes.

How or where can data be obtained?

Proposals should be directed to [email protected]; to gain access, data requestors will
need to sign a data access or material transfer agreement approved by the Murdoch Children’s
Research Institute.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21267	Study protocol			[email protected]
21268	Informed consent form			[email protected]
21269	Ethical approval			[email protected]
21270	Data dictionary			[email protected]
21271	Statistical analysis plan			[email protected]

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.