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Trial registered on ANZCTR


Registration number
ACTRN12619000313134
Ethics application status
Approved
Date submitted
15/02/2019
Date registered
28/02/2019
Date last updated
28/02/2019
Date data sharing statement initially provided
28/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-invasive assessment of pulmonary shunt and ventilation-perfusion status in newborn infants during minimally invasive surfactant therapy
Scientific title
Non-invasive assessment of pulmonary shunt and ventilation-perfusion status in newborn infants during minimally invasive surfactant therapy
Secondary ID [1] 297356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 311482 0
Respiratory distress synrdome 311483 0
Condition category
Condition code
Respiratory 310123 310123 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 310301 310301 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Concentration of inspired oxygen (FiO2).

The amount of inspired oxygen (FiO2) that preterm infant needs to maintain oxygen within target range oxygen saturation (SpO2) of 91-95%, before and after surfactant administration. Before surfactant administration, this will be noted from observation of clinically needed interventions by nurses or doctors caring for the infant. The aim will be to record a minimum of 3 FiO2/SpO2 pairs. If these pairs are not available from clinically indicated change, then FiO2 will be varied in small increments/decrements (of 1-2%) while ensuring is still within target range, i.e. intended SpO2 levels will always be within clinically indicated range, then returning this to the original FiO2 level. The aim will be to have at least 3 pairs of FiO2/SpO2 pairs overall.
This observation will be repeated in the epoch post surfactant administration via minimally invasive surfactant therapy (MIST).

Intervention code [1] 313605 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319014 0
Ventilation perfusion (V:Q) ratio, non-invasively calculated by the Lockwood model
Timepoint [1] 319014 0
Post-surfactant therapy 30-min, 12-hour, 24-hour and 48-hours
Secondary outcome [1] 366719 0
Respiratory support required by infant post sufactant administration.
Respiratory support (non-invasive ventilation e.g. CPAP, NIMV or ventilation via endotracheal tube)
This will be determined from the infants' medical records
Timepoint [1] 366719 0
24 hours post sufactant administration via MIST
Secondary outcome [2] 367240 0
Need for endotracheal intubation as determined from the medical records.
Timepoint [2] 367240 0
24, 48 and 72 hours post MIST surfactant therapy
Secondary outcome [3] 367241 0
Additional surfactant therapy as determined from the medications records
Timepoint [3] 367241 0
6-12 hours post first MIST therapy, assessment over a 30 minute to 1-hour period.

Eligibility
Key inclusion criteria
Preterm infants receiving minimally invasive surfactant therapy (MIST) while treated with non-invasive respiratory support
Infants (born <36+6 weeks gestation)
Diagnosis of Respiratory Distress Syndrome (RDS)
Minimum age
No limit
Maximum age
3 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infant intubated for surfactant therapy
Major congenital anomalies
Infants who are very ill and unstable

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13164 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 25719 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 301920 0
Self funded/Unfunded
Name [1] 301920 0
Address [1] 301920 0
Country [1] 301920 0
Primary sponsor type
Hospital
Name
Monash Newborn
Address
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 301675 0
None
Name [1] 301675 0
Address [1] 301675 0
Country [1] 301675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302605 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302605 0
Research Support Services
Block I, Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 302605 0
Australia
Date submitted for ethics approval [1] 302605 0
Approval date [1] 302605 0
23/01/2019
Ethics approval number [1] 302605 0
45005

Summary
Brief summary
We aim to utilise a novel method for non-invasively estimating the ventilation-perfusion mismatch, a measure of the severity of lung disease of preterm babies with respiratory distress syndrome. The Lockwood algorithm uses routinely measure oxygen saturation levels paired with the amount of oxygen needed in order to calculate how much the oxygen dissociation curve has been "shifted" to provide a measure of the right-left shunt. This study aims to use measures of oxygen levels before and after surfactant treatment and the corresponding ventilation-perfusion levels in order to gauge response of the infant's lungs to surfactant treatment. The hypothesis is that the Lockwood measure will provide robust measure of ventilation-perfusion status in preterm infants with respiratory distress,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90798 0
A/Prof Kenneth Tan
Address 90798 0
Monash Newborn
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 90798 0
Australia
Phone 90798 0
+61 3 85723650
Fax 90798 0
Email 90798 0
kenneth.tan@monash.edu
Contact person for public queries
Name 90799 0
A/Prof Kenneth Tan
Address 90799 0
Monash Newborn
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 90799 0
Australia
Phone 90799 0
+61 3 85723650
Fax 90799 0
Email 90799 0
kenneth.tan@monash.edu
Contact person for scientific queries
Name 90800 0
A/Prof Kenneth Tan
Address 90800 0
Monash Newborn
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 90800 0
Australia
Phone 90800 0
+61 3 85723650
Fax 90800 0
Email 90800 0
kenneth.tan@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results