Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001758897
Ethics application status
Approved
Date submitted
25/11/2021
Date registered
23/12/2021
Date last updated
23/12/2021
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The PALS Study: Picturing Aeration with Lung Ultrasound after Surfactant
Scientific title
The PALS Study: Picturing Aeration with Lung Ultrasound in newborn infants receiving Surfactant
Secondary ID [1] 305891 0
N/A
Universal Trial Number (UTN)
Trial acronym
PALS study (Picturing Aeration with Lung Ultrasound after Surfactant)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 324444 0
neonatal respiratory distress syndrome 324445 0
neonatal respiratory distress 324446 0
Condition category
Condition code
Respiratory 321935 321935 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 322092 322092 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
This observational study aims to determine if surfactant administration (any dose / mechanism of administration) improves lung aeration, as assessed using lung ultrasound, in infants <72hrs old receiving their first dose of surfactant. A 3-second lung ultrasound, performed by a trained researcher, will be captured on the right and left side of the chest at each time point:
- As soon as practicable before surfactant administration
- As soon as practicable after surfactant administration (within 5 minutes)
- 10-20 minutes after surfactant administration
- 1-2 hours after surfactant administration
Each ultrasound will take approximately 1-2 minutes to obtain. At these time points, we will also collect clinical data including oxygen saturation, heart rate, respiratory rate, mode of ventilatory support, fraction of inspired oxygen, mean airway pressure, peak inspiratory pressure and positive end expiratory pressure. Where available, data from blood gas results will also be collected (pH, PaCO2, PaO2, BE, lactate).
For each infant, we will also collect data on patient and maternal demographics (including gestational age, birth weight and gender), mode and timing of surfactant delivery (minimally invasive or via an endotracheal tube), time of birth, time since rupture of membranes, time of birth and patient outcomes (diagnosis, length of NICU admission, time to hospital discharge).
Care for the infant will be dictated by Monash Newborn protocols. If the study is interfering with clinical care of the infant, the lung ultrasound exam will be immediately ceased and will not resume until the medical team feels the infant is stable enough for data collection to continue.
Intervention code [1] 322284 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329689 0
Change in lung ultrasound grade when comparing lung ultrasound video recordings before and after surfactant administration).
Timepoint [1] 329689 0
Within 5 minutes after surfactant administration
Secondary outcome [1] 403456 0

Change in lung ultrasound grade when comparing lung ultrasound video recordings before and after surfactant administration).
Timepoint [1] 403456 0
10-20 minutes after surfactant administration, 1-2 hours after surfactant administration.

Eligibility
Key inclusion criteria
Infants less than or equal to 72 hours old receiving their first dose of surfactant are eligible for this study
Minimum age
No limit
Maximum age
72 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded if they have a congenital abnormality that affects the lungs, like congenital diaphragmatic hernia. We will also exclude the infants of parents who cannot speak English (as verbal consent cannot be obtained).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Infant characteristics will be presented as numbers and proportions for categorical variables, means and SDs for normally distributed continuous variables, and medians and IQRs for variables with skewed distribution. Medical data on each infant will be collected on Case Report Forms. De-identified information will be collected via the Venue 50 ultrasound machine. All information will then be entered into a database for analysis (Microsoft Excel, USA). Imaging statistics will be obtained from de-identified ultrasound recordings using image analysis packages in the Python programming language. Lung ultrasound grade and other imaging variables are continuous and will therefore be compared using a paired samples t-test (if data is normally distributed). Statistical significance will be considered at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21213 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 36080 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 310240 0
Government body
Name [1] 310240 0
Australian Government, Department of Education, Skills and Employment
Country [1] 310240 0
Australia
Primary sponsor type
Individual
Name
Monash Medical Centre
Address
246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 311339 0
None
Name [1] 311339 0
Address [1] 311339 0
Country [1] 311339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309919 0
Monash Health
Ethics committee address [1] 309919 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 309919 0
Australia
Date submitted for ethics approval [1] 309919 0
21/07/2021
Approval date [1] 309919 0
23/11/2021
Ethics approval number [1] 309919 0
78140

Summary
Brief summary
A medication called surfactant is commonly given to preterm newborn babies to help with their breathing. We are conducting a study using ultrasound to measure how quickly surfactant works to help babies who need help breathing. To do this, we will get ultrasound recordings of newborn baby’s lungs before and after surfactant is given. The purpose of this study is to use ultrasound to see how quickly surfactant works. We are using ultrasound of the lungs to monitor how the amount of air in the lungs changes after surfactant treatment. We hope to use the results from this study in the future to improve our care for babies that need surfactant.


If you decide to participate, we will get ultrasound images of your baby’s lungs by gently placing an ultrasound probe on each side of your baby’s chest or back. The lung ultrasound assessments are brief, less than 1 minute. We will perform a total of four ultrasound assessments – one before your baby receives surfactant, and three in the two hours after surfactant is given. The assessments will not interfere with cuddles.

If you don’t wish to take part, you don’t have to. Your baby will continue to receive the best possible care whether you take part or not. The decision to give surfactant, or the way that surfactant is being given, will be decided by the treating doctors and will not be changed by your participation in this study.
Trial website
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 115834 0
Dr Douglas Blank
Address 115834 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 115834 0
Australia
Phone 115834 0
+61 3 8572 3933
Fax 115834 0
Email 115834 0
douglas.blank@monashhealth.org
Contact person for public queries
Name 115835 0
Dr Douglas Blank
Address 115835 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 115835 0
Australia
Phone 115835 0
+61 3 8572 3933
Fax 115835 0
Email 115835 0
douglas.blank@monashhealth.org
Contact person for scientific queries
Name 115836 0
Dr Douglas Blank
Address 115836 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 115836 0
Australia
Phone 115836 0
+61 3 8572 3933
Fax 115836 0
Email 115836 0
douglas.blank@monashhealth.org

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.