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Trial registered on ANZCTR
Registration number
ACTRN12619000314123
Ethics application status
Approved
Date submitted
22/02/2019
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
Using routine pulse oximetry to estimate severity of lung problems in very premature infants.
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Scientific title
Pulmonary ventilation-perfusion status in very preterm infants - non-invasive assessment utilising shift and shunt of the oxygen dissociation curve
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Secondary ID [1]
297435
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prematurity
311613
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Respiratory distress syndrome
311614
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Condition category
Condition code
Respiratory
310239
310239
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0
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
310283
310283
0
0
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Complications of newborn
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Oxygen requirement of preterm infants and corresponding oxgyen saturation (SpO2) to estimate the ventilaton-perfusion (V:Q) ratio. This will be assessed at 3 time-points, at 1 week of age, 28 days and then at 36 weeks corrected gestational age. In brief, the assessment will involve where possible measurement of preductal SpO2 over a 30 minute to 1- hour period.
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Intervention code [1]
313694
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
319187
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Ventilation perfusion (V:Q) ratio, non-invasively calculated by the Lockwood model. This model is a two or three- compartment mathematical model of the lung (ventilation) and blood flow (perfusion) which is coded into a computer program. A minimum of three pair of FiO2/SpO2 pair at each time-point of measurement will provide an output of the V:Q ratio as well as measure of the shift or shunt of the oxygen dissociation curve (ODC) of the infant at that point in time. The computer program was developed by Lockwood et al from the Hammersmith Hospital in London was will be installed on a workstation.
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Assessment method [1]
319187
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Timepoint [1]
319187
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1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age (primary endpoint)
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Secondary outcome [1]
367231
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Respiratory support required by infant from the medical records, whether:
1) ventilation (via endotracheal tube)
2) non-invasive respiratory support (CPAP or NIMV)
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Assessment method [1]
367231
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Timepoint [1]
367231
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1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.
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Secondary outcome [2]
367232
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Oxygen requirement whether there is a need for supplemental oxygen, from the medical records, defined as
1) low -flow oxygen (flow less than 1 L/min)
2) high- flow oxygen (flow above 1 L/min)
and also percentage concentration of oxygen (FiO2)
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Assessment method [2]
367232
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Timepoint [2]
367232
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1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.
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Secondary outcome [3]
367233
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Intubated as having an endotracheal tube in for respiratory support (yes/no) as described in the medical and nursing NICU records.
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Assessment method [3]
367233
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Timepoint [3]
367233
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1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.
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Eligibility
Key inclusion criteria
Preterm infants <32 (or up to 31+6) weeks completed gestation
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Minimum age
0
Hours
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Maximum age
72
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Infants with severe congenital malformation
2) Lack of parental consent
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
13239
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Monash Children’s Hospital - Clayton
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Recruitment postcode(s) [1]
25797
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
302004
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Self funded/Unfunded
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Name [1]
302004
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Address [1]
302004
0
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Country [1]
302004
0
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Primary sponsor type
Hospital
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Name
Monash Newborn
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Address
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
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Country
Australia
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Secondary sponsor category [1]
301878
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None
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Name [1]
301878
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Address [1]
301878
0
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Country [1]
301878
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302680
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
302680
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Research Support Service
Block I, Monash Medical Centre
246, Clayton Road
Clayton
VIC 3168
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Ethics committee country [1]
302680
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Australia
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Date submitted for ethics approval [1]
302680
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Approval date [1]
302680
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21/01/2019
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Ethics approval number [1]
302680
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RES-18-0000-711A
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Summary
Brief summary
The project aims to investigate the longitudinal trajectory of ventilation-perfusion mismatch measured using the Lockwood method in preterm infants less than 32 weeks of age at the end of first week, first month and 36 weeks postmenstrual age. This will be novel non-invasive data which may help to identify those infants at risk of developing bronchopulmonary dysplasia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
91042
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A/Prof Kenneth Tan
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Address
91042
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Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
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Country
91042
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Australia
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Phone
91042
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+61 385723650
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Fax
91042
0
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Email
91042
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[email protected]
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Contact person for public queries
Name
91043
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A/Prof Kenneth Tan
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Address
91043
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Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
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Country
91043
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Australia
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Phone
91043
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+61 385723650
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Fax
91043
0
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Email
91043
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[email protected]
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Contact person for scientific queries
Name
91044
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A/Prof Kenneth Tan
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Address
91044
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Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
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Country
91044
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Australia
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Phone
91044
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+61 385723650
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Fax
91044
0
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Email
91044
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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