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Trial registered on ANZCTR


Registration number
ACTRN12620000337976p
Ethics application status
Submitted, not yet approved
Date submitted
4/02/2020
Date registered
10/03/2020
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of lung function after surfactant administration
Scientific title
Electrical Impedance Tomography, Thoracic Breath Sensor and Lung Ultrasound measurements of Neonates with Respiratory Distress Syndrome during surfactant administration
Secondary ID [1] 300444 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 316107 0
Surfactant deficiency 316108 0
Condition category
Condition code
Respiratory 314396 314396 0 0
Other respiratory disorders / diseases
Respiratory 314397 314397 0 0
Normal development and function of the respiratory system
Reproductive Health and Childbirth 314712 314712 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-randomised three arm study. Group 1 will consist of babies who receive AeroFactTM. Group 2 will be babies who would have met criteria for AeroFactTM treatment but who remain on nCPAP only (“usual care” controls). Group 3 will comprise babies who are on nCPAP but are deemed by their treating clinicians to need intubation and endotracheal surfactant administration. Enrolment will continue sequentially until 10 infants are recruited in group 1, then 20 infants in group 2. Meanwhile, group 3 infants can be recruited at any time during the duration of the study. Lung function will be measured using electrical impedance tomography (EIT) and lung ultrasound and physiological measurements will be taken from prior to surfactant instillation and every 30 minutes until 2 hours post surfactant (or equivalent time in the CPAP only group) by the research nurse. The EIT belt will be placed around the circumference of the chest prior to surfactant instillation and remain for the 2 hour duration of the measurement period with measurements. A 3 minute EIT measurement will be taken prior to surfactant instillation, and then every 30 minutes for 2 hours.
Intervention code [1] 316737 0
Treatment: Other
Comparator / control treatment
Group 2 will be babies who would have met criteria for AeroFactTM treatment but who remain on nCPAP only (“usual care” controls). Babies who do not require escalation of respiratory support will remain on nCPAP at a level of support determined by the treating consultant.
Control group
Active

Outcomes
Primary outcome [1] 322749 0
Ventilation distribution will be measured using electrical impedance tomography
Timepoint [1] 322749 0
Prior to surfactant administration and then every 30 minutes for 2 hours post surfactant
Primary outcome [2] 323060 0
Lung infiltrate amount using lung ultrasound score
Timepoint [2] 323060 0
Prior to and 2 hours post surfactant
Secondary outcome [1] 379560 0
Change in SpO2 will be recorded from the bedside pulse oximeter
Timepoint [1] 379560 0
Prior to surfactant administration and then every 30 minutes for 2 hours post surfactant
Secondary outcome [2] 380629 0
Change in HR will be recorded from the bedside monitor
Timepoint [2] 380629 0
Prior to surfactant administration and then every 30 minutes for 2 hours post surfactant
Secondary outcome [3] 380630 0
Change in FiO2 will be recorded from the ventilator or from the blender.
Timepoint [3] 380630 0
Prior to surfactant administration and then every 30 minutes for 2 hours post surfactant
Secondary outcome [4] 380631 0
Change in RR will be recorded from the bedside monitor
Timepoint [4] 380631 0
Prior to surfactant administration and then every 30 minutes for 2 hours post surfactant

Eligibility
Key inclusion criteria
• Infants 26 0/7 to 31 6/7 weeks corrected gestational age (gestation at birth plus days since birth)
• Weight appropriate for gestational age at birth
• Age < 72 hours
• Currently on nCPAP with an FiO2 requirement <0.30
• Approval of treating medical and nursing staff for recruitment to relevant study arm
• Parent(s) or guardian able and willing to provide informed consent
• At least one parent or guardian aged 18 years or older at the time of consent
• Have not yet received a dose of surfactant
Minimum age
0 Hours
Maximum age
72 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Apgar score less than or equal to 5 at five minutes after birth
• Both parents of baby under 18 years of age (due to the complexities of obtaining consent).
• Prior instillation of surfactant
• Congenital anomaly or syndrome expected to have significant effect on cardio-respiratory function
• Other diseases interfering with cardiopulmonary functions (hydrops fetalis, toxoplasmosis, rubella, cytomegalovirus, herpes simplex)
• Known or suspected chromosomal abnormality
• Concomitant or expected treatment with inhaled nitric oxide
• Any infant with fragile skin where EIT belt placement or TBS placement may damage the skin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size will be 40 infants in total. Group 1 and 3 will have 10 infants each (20 total). Group 2 will have 20 infants which will allow a 2:1 control for Groups 1 and 3. This is an exploratory proof of concept study to describe lung distribution with two types of surfactant delivery (standard liquid bolus versus aerosol) with a control group not receiving surfactant, a power calculation has not been performed. The sample size of 40 is deemed appropriate for a proof of concept, descriptive study, and has been sufficient to demonstrate statistically and clinically significant changes in lung aeration and regional ventilation in other studies of NICU care.
Results will be described using mean and confidence intervals (CI), or standard deviations (SD) for the biometric data. To account for missing data, mixed linear models (MLM) will be used to analyse the impact of surfactant administration on EEL, regional ventilation distribution and physiological variables in each of the three groups. Post hoc analysis will use ANOVA with Bonferroni correction. A p-value of < 0.05 will be considered significant. All statistical analyses will be performed using SPSS (v15.0, Lead Technologies, Inc., Chicago, IL, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
30/11/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15773 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 29206 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304860 0
Hospital
Name [1] 304860 0
Mater Health
Country [1] 304860 0
Australia
Primary sponsor type
Hospital
Name
Mater Health
Address
Department of Neonatology
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 305199 0
Individual
Name [1] 305199 0
Luke Jardine
Address [1] 305199 0
Dept of Neonatology
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 305199 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305270 0
Mater Misercordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 305270 0
Ethics committee country [1] 305270 0
Australia
Date submitted for ethics approval [1] 305270 0
24/01/2020
Approval date [1] 305270 0
Ethics approval number [1] 305270 0

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

Contacts
Principal investigator
Name 99834 0
Dr Judith Hough
Address 99834 0
Dept of Physiotherapy
Mater Health
Raymond Terrace
South Brisbane
Qld 4101
Country 99834 0
Australia
Phone 99834 0
+61422404369
Fax 99834 0
Email 99834 0
[email protected]
Contact person for public queries
Name 99835 0
Judith Hough
Address 99835 0
Dept of Physiotherapy
Mater Health
Raymond Terrace
South Brisbane
Qld 4101
Country 99835 0
Australia
Phone 99835 0
+61422404369
Fax 99835 0
Email 99835 0
[email protected]
Contact person for scientific queries
Name 99836 0
Judith Hough
Address 99836 0
Dept of Physiotherapy
Mater Health
Raymond Terrace
South Brisbane
Qld 4101
Country 99836 0
Australia
Phone 99836 0
+61422404369
Fax 99836 0
Email 99836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not until ethics approval has been obtained.


What supporting documents are/will be available?

No Supporting Document Provided



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.