Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000128291
Ethics application status
Approved
Date submitted
18/01/2018
Date registered
30/01/2018
Date last updated
16/02/2024
Date data sharing statement initially provided
16/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining how babies breathe at birth using Electrical Impedance Tomography
Scientific title
Aeration during Respiratory Transition using Electrical Impedance Tomography in newborn infants (AERATE) Study
Secondary ID [1] 292017 0
Nil Known
Universal Trial Number (UTN)
U1111-1208-0423
Trial acronym
The AERATE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Transition to ex-utero life at birth 303404 0
Prematurity 303407 0
Condition category
Condition code
Reproductive Health and Childbirth 302817 302817 0 0
Complications of newborn
Respiratory 302818 302818 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As soon as practical after birth a custom-built non-adhesive elastic neonatal 32 electrode EIT belt appropriate for estimated birth weight (RIEDEL system, Swisstom AG, Switzerland; CTN-04696-11-04) will be secured with a Velcro fastener around the chest at nipple level of the newly born infant and imaging commenced. A pulse oximetry probe will also be placed on the right hand (Masimo SET pulse oximeter, Masimo Corp., Irvine, CA) to measure preductal peripheral oxygen saturation (SpO2) and heart rate. Clinical care will then proceed as per Neonatal Resuscitation Program guidelines. If respiratory support is applied pressure, flow and tidal volume will be measured using a Florian Respiratory Mechanics monitor (Acutronic, Hizel, Switzerland). The resuscitation will be video recorded. Measurements will cease when the infant is moved from the resuscitation trolley.

There will be no interruption or alteration to normal clinical care.

For preterm infants all measurements will be repeated daily until 72 hours of life (subject to reaffirmation of parental consent) using our previously validated protocol of 6 x two minute recordings over a 30 min period of quiet activity. This will allow us to determine the relationship between the physiological and clinical respiratory events occurring in the Delivery Room and the impact on subsequent respiratory status in NICU.
Intervention code [1] 300072 0
Diagnosis / Prognosis
Intervention code [2] 300073 0
Early Detection / Screening
Comparator / control treatment
The study will enrol 62 infants being born at Term via elective caesarean section or non-insturmental vaginal delivery in which no respiratory support is required (healthy low-risk infants) as a control group. These will be compared to 62 preterm infants <30 weeks and 62 infants 30-35 week gestation. An additional 30 Term infants needing respiratory resuscitation at birth will be studied.
Control group
Active

Outcomes
Primary outcome [1] 304489 0
The primary outcome is the proportion of inflations with a prolonged expiratory time constant during the first 2 mins of life. This outcome is simple, reproducible, quantifiable and its presence represents a unique physiological event associated with successful respiratory transition at birth and is distinctly different from ventilation in the aerated lung later in life. Expiratory time constant (tau) will be calculated via one phase exponential model analysis of time-volume waveform for each inflation recorded by EIT.
Timepoint [1] 304489 0
Two minutes of life.
Secondary outcome [1] 342124 0
The relationship between the proportion of inflations with a prolonged expiratory time constant and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [1] 342124 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.
Secondary outcome [2] 342125 0
The relationship between right-left lung centre of ventilation and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [2] 342125 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.
Secondary outcome [3] 342341 0
The relationship between gravity-dependent centre of ventilation and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [3] 342341 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.
Secondary outcome [4] 342342 0
The relationship between inspiratory time and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [4] 342342 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.
Secondary outcome [5] 342343 0
The relationship between inspiratory flow and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [5] 342343 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.
Secondary outcome [6] 342344 0
The relationship between expiratory flow and need for (and type of) of respiratory support at 10 and 15 min in the Delivery Room, and at subsequent study in the NICU. Between and within each group the associations between EIT measures and each categorical clinical outcomes will be assessed using appropriate regression analysis and sensitivity and specificity calculated.
Timepoint [6] 342344 0
10 and 15 min of life, and end of care in the Delivery Room and then at approximately 24, 48 and 72 hours of life.

Eligibility
Key inclusion criteria
Need for any assessment in the Delivery Room by a health care practitioner at birth, such that participation in the study will not interfere with normal mother-baby interactions. This includes infants being born preterm at any gestation less than 36 weeks, term infants with low-risk of needing resuscitation but still require attendance of a midwife or medical staff, and infants being born via immediate and delayed umbilical cord clamping.
Minimum age
0 Hours
Maximum age
0 Hours
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any infant with known congenital anomalies or pulmonary hypoplasia.
2. Infants born to guardians’ unable to or refusing consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on our pilot data >80% of inflations in term infants (n=6) had a Te that was longer than described during normal tidal breathing, compared to 30-40% in extremely preterm infants (all <30 weeks GA, n=4). If 35%, 60% and 85% of inflations in the <30 weeks GA, 30-34 weeks GA and term stratum have a prolonged Te respectively, 62 infants will be required in each group to detect a significant difference between each group (power 80% and alpha error 0.05). Data will be assessed for normality and appropriate parametric or non-parametric tests applied. The associations between EIT measures and continuous and categorical outcomes will be assessed using appropriate regression analysis.
Based on a technical attainment rate of 90% and the anticipated need for resuscitation in the low-risk healthy term controls of 1 in 7, a total of 78 term infants and 69 infants in the <30 weeks and 30-34 week gestation preterm stratum will be required (total n=216).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
216
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9829 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 18610 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 296541 0
Other
Name [1] 296541 0
Murdoch Children's Research Institute
Country [1] 296541 0
Australia
Funding source category [2] 315856 0
Government body
Name [2] 315856 0
National Health and Medical Research Council
Country [2] 315856 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] 295497 0
None
Name [1] 295497 0
Address [1] 295497 0
Country [1] 295497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297763 0
Royal Women's Hospital Human Ethics and Research Committee
Ethics committee address [1] 297763 0
Ethics committee country [1] 297763 0
Australia
Date submitted for ethics approval [1] 297763 0
04/09/2016
Approval date [1] 297763 0
07/11/2016
Ethics approval number [1] 297763 0
16/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75038 0
A/Prof David Tingay
Address 75038 0
Neonatal Research
Murdoch Children's Research Institute
50 Flemington Road
Parkville Vic 3052
Country 75038 0
Australia
Phone 75038 0
+61393454023
Fax 75038 0
Email 75038 0
[email protected]
Contact person for public queries
Name 75039 0
Elizabeth Perkins
Address 75039 0
Neonatal Research
Murdoch Children's Research Institute
50 Flemington Road
Parkville Vic 3052
Country 75039 0
Australia
Phone 75039 0
+61393454023
Fax 75039 0
Email 75039 0
[email protected]
Contact person for scientific queries
Name 75040 0
David Tingay
Address 75040 0
Neonatal Research
Murdoch Children's Research Institute
50 Flemington Road
Parkville Vic 3052
Country 75040 0
Australia
Phone 75040 0
+61393454023
Fax 75040 0
Email 75040 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
21672Ethical approval  [email protected]
21673Study protocol  [email protected]
21674Informed consent form  [email protected]
21675Statistical 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.