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Trial registered on ANZCTR


Registration number
ACTRN12620000856910
Ethics application status
Approved
Date submitted
9/12/2019
Date registered
28/08/2020
Date last updated
28/08/2020
Date data sharing statement initially provided
28/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nurse performed shortened heart scan for the detection of heart defects in newborn infants.
Scientific title
Nurse performed focused cardiac ultrasound in newborns for the detection of congenital heart disease.
Secondary ID [1] 300037 0
None
Universal Trial Number (UTN)
Trial acronym
NeoFoCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease 315543 0
Condition category
Condition code
Cardiovascular 313827 313827 0 0
Other cardiovascular diseases
Reproductive Health and Childbirth 314050 314050 0 0
Other reproductive health and childbirth disorders
Public Health 314051 314051 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Nurse performed focused cardiac ultrasound protocol. The focused cardiac ultrasound protocol includes 5 transthoracic views and has been developed based on fetal and postnatal echocardiogram techniques.
A minimum of 5 Senior Nurses (Clinical Nurse Specialists, Associate Nurse Unit Managers, Clinical Educators and Nurse Practitioners) within a Tertiary Neonatal Intensive Care Unit will be provided training and support to perform the study intervention. The teaching comprises of a learning module which takes approx 4 hours to complete and provides basic ultrasound principles, the cardiac views relevant to the study, ultrasound machine care and study document information. This will be followed by approx 5 simulation sessions of up to 1hr and 10 supervised practical sessions with PI or cardiac sonographer. Final sign-off of competence will be assessed by a cardiac sonographer or cardiac fellow.
The Nurse performed focused cardiac ultrasound protocol will only be performed once on recruited participants and will take a maximum of 15mins to complete.
The study intervention will be documented in the electronic medical record of the patient as well as any adverse events. The Primary Investigator will access all study intervention images to ensure each patient has a completed study protocol before images are uploaded to a secure organisational network folder for review by 2 cardiologists.
Intervention code [1] 316309 0
Early detection / Screening
Comparator / control treatment
The study intervention will be compared with the full cardiologist performed echocardiogram. The echocardiogram is performed by either a cardiac fellow or cardiac technologist and takes approximately 1 hour to complete. The images are reviewed by a cardiologist and formal report made available. The majority of infants will only require 1 echocardiogram to determine the presence of CHD, however, some infants may require more than 1.
Control group
Active

Outcomes
Primary outcome [1] 322222 0
Outcome- Sensitivity of the Nurse performed focused cardiac ultrasound to detect any form of critical congenital heart defect.
Instrument- Portable ultrasound machine.
Comparator- The Nurse performed focused cardiac ultrasound will be compared against the full echocardiogram which is the gold standard for postnatal congenital heart disease detection.
Timepoint [1] 322222 0
Within 1 month of the study intervention.
Primary outcome [2] 322450 0
Outcome- Specificity of the Nurse performed focused cardiac ultrasound to detect any form of critical congenital heart defect.
Instrument- Portable ultrasound machine.
Comparator- The Nurse performed focused cardiac ultrasound will be compared against the full echocardiogram which is the gold standard for postnatal congenital heart disease detection.
Timepoint [2] 322450 0
Within 1 month of the study intervention.
Secondary outcome [1] 377792 0
Outcome- Proportion of critical congenital heart disease infants categorised as obstruction to pulmonary blood flow..
Instrument- Portable ultrasound machine.
Timepoint [1] 377792 0
Within 1 month of the study intervention.
Secondary outcome [2] 377793 0
Outcome- Determine the effectiveness of a focused cardiac ultrasound teaching module for ultrasound naïve nurses.
Instrument- time to complete package and number of practical sessions required to reach competence which will be recorded in the study record log book within the teaching module (composite outcome).
Timepoint [2] 377793 0
Checked fortnightly until completion of the theoretical components and competence of practice skills as signed off by cardiac fellow or cardiac technologist.
Secondary outcome [3] 378580 0
Outcome- Proportion of critical congenital heart disease infants categorised as obstruction to systemic blood flow.
Instrument- Portable ultrasound machine.
Timepoint [3] 378580 0
Within 1 month of the study intervention.
Secondary outcome [4] 378581 0
Outcome- Proportion of critical congenital heart disease infants categorised as complex congenital heart disease.
Instrument- Portable ultrasound machine.
Timepoint [4] 378581 0
Within 1 month of the study intervention.
Secondary outcome [5] 385219 0
Acceptability of the focused cardiac ultrasound teaching module.
Instrument- face-to-face interview tool specifically designed for the study to gather participant feedback.
Timepoint [5] 385219 0
Face-to-face interview will be conducted within 4 weeks of completion of the teaching module

Eligibility
Key inclusion criteria
- Newborn infants 30 days of life or less
- Having an inpatient echocardiogram as part of their illness work-up.
- Parental or legal guardian consent.
Minimum age
No limit
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major congenital anomaly, other than potential congenital heart disease, that may prevent a focused cardiac ultrasound from being performed or harm may be caused by performing the ultrasound.
- Life threatening situations where performing the focused cardiac ultrasound may destabilise the patient further.
- Cardiac surgery.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Accrual is expected to be completed within 18-24 months. Sample size estimates to assess sensitivity and specificity are based on loose figures from previous years presentations. Approximately 70 - 130 newborns over a 12 month period will be definitively diagnosed with critical congenital heart disease. To address specificity there are several groups of patients who can be included that do not have the disease. These groups include, midline congenital anomaly screens, pre-operative patients, infants with persistent pulmonary hypertension of the newborn, PDA assessment related to prematurity, cardiovascular function evaluation and for arrythmia assessment (not structural heart disease related). Based on figures provided by the Cardiology Department approximately 40 newborns less than 30 days of age per week have an echo for non critical congenital heart disease indications as outlined above. Therefore over a maximum 2 year period there will likely be over 900 newborns who could be enrolled, which is adequate to address specificity.
Healthy newborns (without one of the indications above) will not be used in this study as they will not be having an echo as part of their routine management.
Estimation of the sensitivity and specificity of the cardiac focused ultrasound will depend on the number of critical congenital heart disease patients and non-critical congenital heart disease patients, respectively. Thus, if there are 70 CCHD patients the sensitivity would be estimated with a maximum standard error of 6% (based on a sensitivity of 50%). Higher estimates of sensitivity (or specificity) or increased sample size will result in narrower confidence intervals, i.e., higher precision. For example, if 56 of 70 CCHD subjects are detected by the cardiac focused ultrasound the 95% confidence interval for sensitivity (80%) will be 71% – 89%.
Descriptive statistics of baseline characteristics and demographic data will be reported. Mean and standard deviation and median and Interquartile Range (IQR) will be used to describe parametric and non-parametric data respectively.
The primary objective will be measured by the sensitivity and specificity. Sensitivity will be estimated by the proportion of true positives out of all CCHD patients (as determined by the full ECHO (gold standard)). Specificity will be estimated by the proportion of true negatives out of all non-CCHD patients (as determined by the full ECHO (gold standard)). Corresponding 95% confidence intervals will be calculated using the exact probabilities of the binomial distribution.
Due to the subjective nature of the diagnosis made from the focused cardiac US protocol, interrater variability will be examined. Kappa and percentage agreement analysis will be used to assess interrater variability between the two reviewing cardiologists.
Thematic analysis will be used to report qualitative data. Thematic analysis is best used to look at interview data to identify patterned meaning across the dataset. Themes are identified through a rigorous process of data familiarisation, coding, and theme development with revision and statistical analysis applied to validate themes. Critical congenital heart disease category results will be described using proportions. Mean and standard deviation and median and IQR will be used to describe parametrical and non-parametric data respectively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2020
Date of last participant enrolment
Anticipated
16/01/2022
Actual
Date of last data collection
Anticipated
30/01/2022
Actual
Sample size
Target
140
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28763 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 304490 0
University
Name [1] 304490 0
University of Melbourne Graduate Research Scholarship
Country [1] 304490 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 304757 0
Hospital
Name [1] 304757 0
Royal Children's Hospital
Address [1] 304757 0
Flemington Road Parkville VIC 3052
Country [1] 304757 0
Australia
Secondary sponsor category [2] 304758 0
Hospital
Name [2] 304758 0
Murdoch Children's Research Institute
Address [2] 304758 0
Flemington Road Parkville VIC 3052
Country [2] 304758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304922 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 304922 0
50 Flemington Road
Parkville Victoria 3052
Ethics committee country [1] 304922 0
Australia
Date submitted for ethics approval [1] 304922 0
13/11/2019
Approval date [1] 304922 0
17/02/2020
Ethics approval number [1] 304922 0

Summary
Brief summary
The primary purpose of this study is to determine the diagnostic accuracy of a nurse performed shortened heart scan protocol to detect severe heart defects in newborn infants 30 days of life or less.
The study team hypothesise that the nurse performed shortened heart scan can accurately detect severe heart defects in newborns 30 days of age or less.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98650 0
Mrs Sally Jeston
Address 98650 0
Royal Children's Campus/Royal Children's Hospital
Level 5
50 Flemington Road Parkville VIC 3052
Country 98650 0
Australia
Phone 98650 0
+61 422917810
Fax 98650 0
Email 98650 0
[email protected]
Contact person for public queries
Name 98651 0
Sally Jeston
Address 98651 0
Royal Children's Campus/Royal Children's Hospital
Level 5
50 Flemington Road Parkville VIC 3052
Country 98651 0
Australia
Phone 98651 0
+61 422917810
Fax 98651 0
Email 98651 0
[email protected]
Contact person for scientific queries
Name 98652 0
Sally Jeston
Address 98652 0
Royal Children's Campus/Royal Children's Hospital
Level 5
50 Flemington Road Parkville VIC 3052
Country 98652 0
Australia
Phone 98652 0
+61 422917810
Fax 98652 0
Email 98652 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
Participants will be issued with a summary of the overall project results. Individual participant results will not be shared to maintain confidentiality.


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.