Trial Review

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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.
Scientific title
Pulmonary ventilation-perfusion status in very preterm infants - non-invasive assessment utilising shift and shunt of the oxygen dissociation curve
Secondary ID [1] 297435 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 311613 0
Respiratory distress syndrome 311614 0
Condition category
Condition code
Respiratory 310239 310239 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 310283 310283 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
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.
Intervention code [1] 313694 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319187 0
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.
Timepoint [1] 319187 0
1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age (primary endpoint)
Secondary outcome [1] 367231 0
Respiratory support required by infant from the medical records, whether:
1) ventilation (via endotracheal tube)
2) non-invasive respiratory support (CPAP or NIMV)
Timepoint [1] 367231 0
1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.
Secondary outcome [2] 367232 0
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)
Timepoint [2] 367232 0
1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.
Secondary outcome [3] 367233 0
Intubated as having an endotracheal tube in for respiratory support (yes/no) as described in the medical and nursing NICU records.
Timepoint [3] 367233 0
1) 5- 7 days of life.
2) 28 days of life
3) 36 weeks corrected gestational age.

Eligibility
Key inclusion criteria
Preterm infants <32 (or up to 31+6) weeks completed gestation
Minimum age
0 Hours
Maximum age
72 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Infants with severe congenital malformation
2) Lack of parental consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13239 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 25797 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302004 0
Self funded/Unfunded
Name [1] 302004 0
Country [1] 302004 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] 301878 0
None
Name [1] 301878 0
Address [1] 301878 0
Country [1] 301878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302680 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302680 0
Research Support Service
Block I, Monash Medical Centre
246, Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 302680 0
Australia
Date submitted for ethics approval [1] 302680 0
Approval date [1] 302680 0
21/01/2019
Ethics approval number [1] 302680 0
RES-18-0000-711A

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91042 0
A/Prof Kenneth Tan
Address 91042 0
Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 91042 0
Australia
Phone 91042 0
+61 385723650
Fax 91042 0
Email 91042 0
[email protected]
Contact person for public queries
Name 91043 0
Kenneth Tan
Address 91043 0
Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 91043 0
Australia
Phone 91043 0
+61 385723650
Fax 91043 0
Email 91043 0
[email protected]
Contact person for scientific queries
Name 91044 0
Kenneth Tan
Address 91044 0
Monash Newborn,
Monash Children's Hospital
246 Clayton Road
Clayton
VIC 3168
Country 91044 0
Australia
Phone 91044 0
+61 385723650
Fax 91044 0
Email 91044 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


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.