ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bronchopulmonary Dysplasia

Preterm

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Lung ultrasound score correlated with current respiratory support status (mean airway pressure and fractional inspired oxygen concentration provision).

Timepoint [1]

Day 1, day 3-4, day 7, day 28 and 36 weeks PMA.

Secondary outcome [2]

The predictive value of lung ultrasound score on day 1 to predict early successful extubation from ventilatory support to non-invasive CPAP.

Timepoint [2]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

University

Name [1]

Centre for Neonatal Research and Education, University of Western Australia

Address [1]

CNRE
Level 1, King Edward Memorial Hospital
Bagot Road
Subiaco
Perth
WA 6008

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Channel 7 Telethon Trust WIRF

Address [2]

Womens and Infants Research Foundation,
King Edward Memorial Hospital
Bagot Road
Subiaco
Perth
WA 6008

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women and Newborn Health Services

Ethics committee address [1]

Research Governance 

Women and Newborn Health Service

O Block, KEMH, Subiaco, WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/09/2016

Approval date [1]

04/10/2016

Ethics approval number [1]

2016130ew

Summary

Brief summary

Lung ultrasound is widely used within adult critical care with international evidence based recommendations for its utility in the assessment of patients with respiratory compromise. Further research is required to validate its clinical application within neonatal intensive care. Lung ultrasound is an attractive bedside clinical tool that is simple, non-invasive, quick to perform and well tolerated by even the most preterm of babies, using ultrasound equipment already in routine use.
Bronchopulmonary dysplasia (BPD) is a process that starts soon after birth in preterm infants, with scarring and inflammatory changes within the lungs that may be slow to appear on conventional chest x-ray. Lung ultrasound performed in the first week of life may be more sensitive in recognising these changes earlier with the potential to assist in prediction of BPD and better direct therapeutic interventions (Raimondi et al 2014).
A prospective observational cohort study will be undertaken performing lung ultrasound in 100 preterm infants born <28 weeks’ gestation admitted to KEMH neonatal intensive care unit receiving respiratory support. The study aims to determine if lung ultrasound can predict the development of BPD and respiratory outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Patricia Woods

Address

Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008

Country

Australia

Phone

+61 08 64581186

Fax

[email protected]

Contact person for public queries

Name

Patricia Woods

Address

Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008

Country

Australia

Phone

+61 08 64581186

Fax

[email protected]

Contact person for scientific queries

Name

Patricia Woods

Address

Neonatal Clinical Care Unit, 1st Floor, King Edward Memorial Hospital,
374 Bagot Rd, Subiaco
Perth
Western Australia 6008

Country

Australia

Phone

+61 08 64581186

Fax

[email protected]

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

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Basic results	No		372293-(Uploaded-16-09-2020-16-24-28)-Basic results summary.docx
Plain language summary	No	LUS in the first week of life predicted the severi... [More Details]
Study results article	Yes	Your article DOI is: http://dx.doi.org/10.1136/a... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Early lung ultrasound affords little to the prediction of bronchopulmonary dysplasia.	2021	https://dx.doi.org/10.1136/archdischild-2020-320830

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically