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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] 311232 0
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 332438 0
Respiratory Support 332439 0
Prematurity 332440 0
Condition category
Condition code
Reproductive Health and Childbirth 329129 329129 0 0
Complications of newborn
Respiratory 329130 329130 0 0
Normal development and function of the respiratory system
Respiratory 329131 329131 0 0
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] 327688 0
Diagnosis / Prognosis
Intervention code [2] 327689 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336965 0
Gravity dependent centre of ventilation
Timepoint [1] 336965 0
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] 430264 0
Center of ventilation along the right-left plane of the lung
Timepoint [1] 430264 0
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] 430265 0
Percentage of the lung that is not engaged in tidal ventilation (termed silent spaces)
Timepoint [2] 430265 0
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] 430266 0
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] 430266 0
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] 430267 0
Relative aeration state of the lung
Timepoint [4] 430267 0
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] 430268 0
Relative gas flow within the lung
Timepoint [5] 430268 0
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] 430269 0
Modified Oxygenation index
Timepoint [6] 430269 0
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] 430270 0
Bronchopulmonary Dysplasia grade
Timepoint [7] 430270 0
36 weeks corrected post-mensural age
Secondary outcome [8] 430271 0
Death
Timepoint [8] 430271 0
Anytime during NICU admission
Secondary outcome [9] 430272 0
Maximum Level of respiratory support during primary NICU admission
Timepoint [9] 430272 0
Anytime during NICU admission
Secondary outcome [10] 430273 0
Pneumothorax
Timepoint [10] 430273 0
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] 41799 0
3052 - Parkville
Recruitment postcode(s) [2] 41800 0
3084 - Heidelberg
Recruitment postcode(s) [3] 41801 0
3168 - Clayton
Recruitment postcode(s) [4] 41802 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 315489 0
Government body
Name [1] 315489 0
National Health and Medical Research Council
Country [1] 315489 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
50 Flemington Rd Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 317564 0
None
Name [1] 317564 0
Address [1] 317564 0
Country [1] 317564 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314394 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 314394 0
50 Flemington Rd Parkville, Victoria 3052
Ethics committee country [1] 314394 0
Australia
Date submitted for ethics approval [1] 314394 0
28/02/2024
Approval date [1] 314394 0
19/06/2024
Ethics approval number [1] 314394 0
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 131426 0
Prof David Tingay
Address 131426 0
Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052
Country 131426 0
Australia
Phone 131426 0
+61 393454023
Fax 131426 0
Email 131426 0
[email protected]
Contact person for public queries
Name 131427 0
David Tingay
Address 131427 0
Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052
Country 131427 0
Australia
Phone 131427 0
+61 393454023
Fax 131427 0
Email 131427 0
[email protected]
Contact person for scientific queries
Name 131428 0
David Tingay
Address 131428 0
Murdoch Children's Research Institute, 50 Flemington Rd Parkville, Victoria 3052
Country 131428 0
Australia
Phone 131428 0
+61 393454023
Fax 131428 0
Email 131428 0
[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.TypeCitationLinkEmailOther DetailsAttachment
21267Study protocol  [email protected]
21268Informed consent form  [email protected]
21269Ethical approval  [email protected]
21270Data dictionary  [email protected]
21271Statistical analysis plan  [email protected]



Results publications and other study-related documents

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