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Trial registered on ANZCTR


Registration number
ACTRN12617000208303
Ethics application status
Approved
Date submitted
6/02/2017
Date registered
8/02/2017
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictive Value of Bedside Lung Ultrasound in Preterm Infants with Respiratory Distress and the Evolution of Bronchopulmonary Dysplasia
Scientific title
Predictive Value of Bedside Lung Ultrasound in Preterm Infants with Respiratory Distress and the Evolution of Bronchopulmonary Dysplasia
Secondary ID [1] 291092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchopulmonary Dysplasia 301901 0
Preterm 301902 0
Condition category
Condition code
Respiratory 301569 301569 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 301588 301588 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
Diagnostic assessment: Serial bedside lung ultrasounds will be performed on three occasions in the first week of life (day 1, day 3-4, day 7), day 28 and between 35 weeks +0 days to 36 weeks +6 days postmenstrual age. Ultrasounds will be performed in conjunction with clinician performed bedside cardiac or cranial ultrasound assessments as part of routine care or coinciding with PIFCO assessment on day 7 if enrolled (Preterm Infant Functional and Clinical Outcome (PIFCO) Study: 2013091E/W) and the scheduled ANZNN Shift Test.

Lung Ultrasound Protocol
Bedside ultrasound examinations are to be performed with the infant nursed in a supine position on radiant warmer or incubator, with continuous cardiovascular and respiratory monitoring in situ. Measures will be employed to optimise thermal care and patient comfort during the procedure such as pre-warmed jelly and a sterile NeoWrap sheet placed over infant. The duration of any lung ultrasound examination will be limited to a maximum of 5 minutes to avoid patient discomfort and minimise excessive handling.
Philips iE33 ultrasound machine in current use for clinician performed ultrasounds in KEMH NICU, utilising a high resolution 11-3 MHz linear probe with dedicated lung pre-set, focus point at pleural line, depth 2.5 cm, duration of video loops lasting 6 seconds encompassing full respiratory cycles. All will be acquired in a standardised sequence.
The project will include development of an interactive training module and assessment to standardise the way lung ultrasounds are performed. We will also generate a scoring system from the first 50 patients to develop a predictive statistical model for the development of BPD to be applied to a further 50 recruited patients.
Intervention code [1] 297079 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300978 0
Lung ultrasound scores on day 1, day3-4, day 7, day 28 and 36 weeks postmenstrual age, correlated with results of ANZNN SHIFT Test performed at 36weeks PMA.

Timepoint [1] 300978 0
Lung Ultrasounds: Day 1, day 3-4, day 7, day 28 and 36 weeks PMA.
ANZNN SHIFT Test at 36 weeks PMA.
Secondary outcome [1] 331316 0
Lung ultrasound score correlated with current respiratory support status (mean airway pressure and fractional inspired oxygen concentration provision).
Timepoint [1] 331316 0
Day 1, day 3-4, day 7, day 28 and 36 weeks PMA.
Secondary outcome [2] 331345 0
The predictive value of lung ultrasound score on day 1 to predict early successful extubation from ventilatory support to non-invasive CPAP.
Timepoint [2] 331345 0
Non-invasive ventilatory support at 48 hours and at 72 hours.

Eligibility
Key inclusion criteria
1) Preterm infants born less than 28 completed weeks gestation; 2) Admission to the KEMH NICU within 24 hours of birth; 2) Requirement for any modality of respiratory support; 4) Informed parental assent to undertake ultrasounds in NICU in conjunction with scheduled examinations. Given the practical difficulties in obtaining written parental consent within 24 hours of birth in an extremely preterm infant, and mindful approach to limiting parental stress and avoidance of excessive burden of information, ultrasound images will only be included in this study and analysed if parental consent is obtained at the earliest possibility prior to day 3.
Minimum age
1 Hours
Maximum age
24 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outborn infants birthed in a non-tertiary institution subsequently transferred to KEMH NICU will be excluded from the study given lower rates of complete antenatal steroid coverage and optimal conditions for resuscitation, early stabilisation and documented poorer outcomes. Exclusion will also apply to major congenital abnormalities affecting the thoracic organs, or control of breathing.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Our primary hypothesis is that lung ultrasound will be an accurate predictor of an infant developing BPD as defined by the Shift Test score ranging from <9.5 to >35 kPa. A significant advantage of this study is the use of a physiological measurement of BPD as a continuous variable, rather than a dichotomous outcome at exactly 36 weeks PMA as previously specified. The most important time period of performing lung ultrasound (scored on day 1, day 3-4, day 7, day 28 and week 36) will be identified cross-sectionally using linear regression models. These models will identify the best predictive timing of lung ultrasound on shift test. All models will test the confounding influences of known clinical and demographic risk factors such as birthweight z-score, gestation, gender and respiratory support.
In a secondary analysis, we will compare results of application of the predictive statistical model to recently superseded ANZNN definition of BPD as a dichotomous outcome. Repeated measurements of lung ultrasound scores on infants will be accommodated using mixed linear regression models for the continuous outcome of the Shift Test and Generalised Estimating Equations for a binary outcome.
How lung ultrasound features relate to concurrent respiratory, cardiac and fluid status will be examined by correlation coefficients. The predictive value of lung ultrasound score on day 1 to predict successful extubation from ventilatory support to non-invasive CPAP by 48-72 hours will also be assessed by logistic regression.
Interim analysis is planned after the successful recruitment of the first 50 infants, allowing for a more accurate minimum sample size for the second phase to be determined. The Cohen K coefficient will be used to assess interobserver variability in lung ultrasound scoring by blinded assessors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
10/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7441 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 15253 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 295532 0
University
Name [1] 295532 0
Centre for Neonatal Research and Education, University of Western Australia
Country [1] 295532 0
Australia
Funding source category [2] 295534 0
Charities/Societies/Foundations
Name [2] 295534 0
Channel 7 Telethon Trust WIRF
Country [2] 295534 0
Australia
Primary sponsor type
Hospital
Name
Neonatal Clinical Care Unit
Address
Level 1, King Edward Memorial Hospital
Bagot Road
Subiaco
Perth
WA 6008
Country
Australia
Secondary sponsor category [1] 294369 0
None
Name [1] 294369 0
Address [1] 294369 0
Country [1] 294369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296853 0
Women and Newborn Health Services
Ethics committee address [1] 296853 0
Ethics committee country [1] 296853 0
Australia
Date submitted for ethics approval [1] 296853 0
06/09/2016
Approval date [1] 296853 0
04/10/2016
Ethics approval number [1] 296853 0
2016130ew

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

Contacts
Principal investigator
Name 72230 0
Dr Patricia Woods
Address 72230 0
Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008
Country 72230 0
Australia
Phone 72230 0
+61 08 64581186
Fax 72230 0
Email 72230 0
Patricia.Woods@health.wa.gov.au
Contact person for public queries
Name 72231 0
Patricia Woods
Address 72231 0
Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008
Country 72231 0
Australia
Phone 72231 0
+61 08 64581186
Fax 72231 0
Email 72231 0
Patricia.Woods@health.wa.gov.au
Contact person for scientific queries
Name 72232 0
Patricia Woods
Address 72232 0
Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008
Country 72232 0
Australia
Phone 72232 0
+61 08 64581186
Fax 72232 0
Email 72232 0
Patricia.Woods@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 372293-(Uploaded-16-09-2020-16-24-28)-Basic results summary.docx
Plain language summaryNo LUS in the first week of life predicted the severi... [More Details]
Study results articleYes Your article DOI is: http://dx.doi.org/10.1136/a... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly lung ultrasound affords little to the prediction of bronchopulmonary dysplasia.2021https://dx.doi.org/10.1136/archdischild-2020-320830
N.B. These documents automatically identified may not have been verified by the study sponsor.