Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001584729
Ethics application status
Approved
Date submitted
14/12/2022
Date registered
22/12/2022
Date last updated
22/12/2022
Date data sharing statement initially provided
22/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing the clinical audit and implementation of neonatal brain MRI for North-Queensland infants at high-risk for adverse neurodevelopmental outcomes
Scientific title
Pilot testing the clinical audit and implementation of neonatal brain MRI for North-Queensland infants at high-risk for adverse neurodevelopmental outcomes
Secondary ID [1] 308620 0
TAAHC Application SF0000421
Universal Trial Number (UTN)
Trial acronym
NMNQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 328513 0
Low birth weight 328514 0
Hypoxic event at birth 328515 0
Brain injury in neonates 328516 0
Severe intraventricular haemorrhage (Grade III-IV) 328517 0
Condition category
Condition code
Reproductive Health and Childbirth 325538 325538 0 0
Complications of newborn
Neurological 325594 325594 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves one neonatal brain Magnetic Resonance Imaging (MRI) scan (without general anesthesia or sedation) at or before term-equivalent age for infants identified at high risk of adverse outcomes. The first 21 infants per site to be successfully scanned are included for this study.
The scan will take an hour, which includes the preparation and MRI scanning time. The feed-and-wrap method will be used for scanning, which is non-invasive and has been successful in previous studies in Brisbane (of which several investigators are also taking part in this current trial, PPREMO ACTRN12613000280707 and PREBO ACTRN12615000591550). Before the brain MRI scan, parents will be asked to feed their baby, which often results in the baby falling asleep during the scan. The baby will then be placed in the scanner wrapped in a blanket or muslin cloth while lying on an immobilisation pillow (comfortable beanbag) to reduce movement, while vitals are monitored during the scan. Oxygen saturation and heart rate monitors are monitoring the baby’s vitals by placing a sensor on the infant’s hand or feet. An MRI can be loud, so infants will wear MR compatible noise-attenuating ear muffs. Only infants who are medically stable will be considered for a neonatal MRI scan for this study. Note, no sedation or anaesthesia will be used. A clinician (e.g., research nurse) will monitor and care for the infant during the transfer and during the MRI scanning. The scan will only take place if the baby settles. The MRI will not be performed is the infant is not comfortable and does not settle. An MRI recording sheet will record whether the MRI was undertaken and whether the scan quality was successful.

Other measures: Parents/guardians will be asked to fill out a social risk survey (Roberts et al. 2008). Permission will be obtained for retrieving information from the database in relation to the infants' development during the first two years of life (see outcome section)
Intervention code [1] 325071 0
Diagnosis / Prognosis
Intervention code [2] 325072 0
Early detection / Screening
Comparator / control treatment
A retrospective dataset from 2015-2020 derived from the Townsville University and Cairns Hospital databases will be used for comparison, including infants at high risk who received no early neonatal MRI before or at term-age (but may have received a later MRI as part of standard usual care) .
Control group
Historical

Outcomes
Primary outcome [1] 333380 0
The number of infants identified as high risk around 3 months of corrected age (primary outcome) assessed by using a composite of brain MRI and the general movements assessment
Timepoint [1] 333380 0
3 months (primary timepoint)
Primary outcome [2] 333381 0
The number of early referrals to services and intervention (primary outcomes) - assessed by audit of patient medical records
Timepoint [2] 333381 0
1 year corrected age (primary timepoint)
Primary outcome [3] 333382 0
The costs, consequences and risks for neonatal MRI (before or at term age) vs no or late MRI (>4 months' corrected age) in infants at high risk (primary outcome), reported as the incremental cost-effectiveness ratio. This will be evaluated with the Health Resource Use Questionnaire.
Timepoint [3] 333382 0
1 year corrected age (primary timepoint)
Secondary outcome [1] 416852 0
The number of infants identified as high risk at follow-up (primary outcome) assessed by clinical measures collected as part of standard usual care (e.g., The Hammersmith Infant Neurological Examination and/or Bayley Scales of Infant and Toddler Development ) ( this is an additional composite primary outcome)
Timepoint [1] 416852 0
1 year corrected age
Secondary outcome [2] 416978 0
The number of infants identified as high risk at follow-up (primary outcome) assessed by clinical measures collected as part of standard usual care (e.g., The Hammersmith Infant Neurological Examination and/or Bayley Scales of Infant and Toddler Development ) - This is an additional composite primary outcome
Timepoint [2] 416978 0
2 years corrected age
Secondary outcome [3] 416979 0
The number of early diagnosis - assessed by audit of patient medical records
Timepoint [3] 416979 0
1 year corrected age
Secondary outcome [4] 416980 0
The number of early diagnosis - assessed by audit of patient medical records
Timepoint [4] 416980 0
2 years corrected age
Secondary outcome [5] 416981 0
The number of early referrals to services and intervention - assessed by audit of patient medical records
Timepoint [5] 416981 0
2 years corrected age
Secondary outcome [6] 416982 0
The costs, consequences and risks for neonatal MRI (before or at term age) vs no or late MRI (>4 months' corrected age) in infants at high risk (primary outcome), reported as the incremental cost-effectiveness ratio. This will be evaluated with the Health Resource Use Questionnaire.
Timepoint [6] 416982 0
2 years corrected age
Secondary outcome [7] 416983 0
Neurological development around 3-5 months' corrected age assessed by the Hammersmith Infant Neurological Examination
Timepoint [7] 416983 0
3-5 months corrected age
Secondary outcome [8] 416984 0
Neurological development around 8-12 months' corrected age assessed by the Hammersmith Infant Neurological Examination
Timepoint [8] 416984 0
8-12 months corrected age
Secondary outcome [9] 416985 0
Cognitive neurodevelopmental outcomes including motor, cognitive and language abilities assessed by the Bayley Scales of Infant and Toddler Development (BSID) 3rd or 4th edition around 12 months' corrected age.
Timepoint [9] 416985 0
12 months corrected age
Secondary outcome [10] 416986 0
Cognitive neurodevelopmental outcomes including motor, cognitive and language abilities assessed by the Bayley Scales of Infant and Toddler Development (BSID) 3rd or 4th edition around 24 months' corrected age.
Timepoint [10] 416986 0
24 months corrected age
Secondary outcome [11] 416987 0
Motor development assessed by the Neuro Sensory Motor Developmental Assessment (NSMDA) measuring motor development around 12 months' corrected age.
Timepoint [11] 416987 0
12 months' corrected age
Secondary outcome [12] 416988 0
Motor development assessed by the Neuro Sensory Motor Developmental Assessment (NSMDA) measuring motor development around 24 months' corrected age.
Timepoint [12] 416988 0
24 months' corrected age
Secondary outcome [13] 416989 0
Socio-economic risk status assessed using the social risk questionnaire developed by Roberts et al. 2018 before or at term-equivalent age
Timepoint [13] 416989 0
Before or at term-equivalent age

Eligibility
Key inclusion criteria
Infants at risk including: (1) those born very preterm (<32 weeks gestational age), (2) those born with low birth weight (< 1500g), (3) those small for gestational age, (4) whom had a hypoxic event (e.g., Hypoxic ischaemic encephalopathy (HIE)) and /or (5) with severe intraventricular haemorrhage (Grade III-IV) or (6) those identified based on clinical grounds (such as an indication of brain injury from the cranial ultrasound). All infants will be scanned before or at term-equivalent age, except for infants born at term, who will be scanned within 7 days of delivery (e.g., those with HIE).
Minimum age
No limit
Maximum age
42 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following will be excluded: (1) Infants with known major congenital or chromosomal abnormalities (as identified as part of standard care), (2) those not treated at Townsville or Cairns Hospital’s Neonatal unit, (3) those not medically stable (on ventilator) before or at term-equivalent age (i.e., infants need to be stable for a neonatal MRI), (4) infants who are unlikely to return to Townsville University or Cairns hospital for follow-up, or (5) families not able to give informed consent (due to diminished understanding and/or unable to understand or speak English while an interpreter is unavailable).

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
We will recruit 42 infants at risk of adverse neurodevelopmental outcomes (21 per site) who will receive a neonatal MRI. We expect to derive at least this number of infants from the retrospective cohort as well (that is, those infants at risk who received standard care (no or a later MRI >4 months C.A.)). Significance binomial testing to examine binomial outcome differences (e.g., diagnosis of Cerebral Palsy Yes or No, early referral Yes or No) between infants who received a neonatal MRI versus those who received standard care (derived from the retrospective cohort) requires at least n=28 in total when power is set to 0.95 and alpha 0.05 (calculated in GPower 3.1.9.7). Our pilot aims to include at least 42 infants in each group for the analyses instead of the required 28, to mitigate for any drop-out due to follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
29/12/2025
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23721 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 23739 0
Cairns Hospital - Cairns
Recruitment postcode(s) [1] 39159 0
4814 - Douglas
Recruitment postcode(s) [2] 39181 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 312859 0
Other Collaborative groups
Name [1] 312859 0
Tropical Australian Academic Health Centre
Country [1] 312859 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook University
1 James Cook Drive
Townsville QLD 4811 Australia
Country
Australia
Secondary sponsor category [1] 314517 0
None
Name [1] 314517 0
Address [1] 314517 0
Country [1] 314517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312137 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 312137 0
Ethics committee country [1] 312137 0
Australia
Date submitted for ethics approval [1] 312137 0
26/04/2022
Approval date [1] 312137 0
22/08/2022
Ethics approval number [1] 312137 0
HREC/22/QCHQ/86270

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

Contacts
Principal investigator
Name 123610 0
Dr Liza van Eijk
Address 123610 0
James Cook University
1 James Cook Drive Townsville QLD 4811
Country 123610 0
Australia
Phone 123610 0
+61 7 4781 5823
Fax 123610 0
Email 123610 0
[email protected]
Contact person for public queries
Name 123611 0
Liza van Eijk
Address 123611 0
James Cook University
1 James Cook Drive Townsville QLD 4811
Country 123611 0
Australia
Phone 123611 0
+61 7 4781 5823
Fax 123611 0
Email 123611 0
[email protected]
Contact person for scientific queries
Name 123612 0
Liza van Eijk
Address 123612 0
James Cook University
1 James Cook Drive Townsville QLD 4811
Country 123612 0
Australia
Phone 123612 0
+61 7 4781 5823
Fax 123612 0
Email 123612 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
MRIs in combination with clinical information will risk the identification of infants and their families participating in the study.


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.