RecruitingACTRN12622001584729

Pilot testing the clinical audit and implementation of neonatal brain MRI for North-Queensland infants at high-risk for adverse neurodevelopmental outcomes

Sponsor

James Cook University

Enrollment

42 participants

Start Date

Jul 1, 2024

Study Type

Interventional

Conditions

Severe intraventricular haemorrhage (Grade III-IV)Brain injury in neonates Hypoxic event at birth

Summary

This project will test the implementation and clinical utility of neonatal brain MRI at Townsville University Hospital and Cairns Hospital for infants at high-risk for adverse neurodevelopmental outcomes. Infants born preterm, with low birth weight, who have a hypoxic event at birth and/or a brain injury are at high risk for adverse neurodevelopmental outcomes. An MRI can provide detailed and accurate information about brain injury and growth impairments to assist with risk stratification, however, currently, the timing of MRI is variable, with the MRI often performed at an age when general anaesthesia is required (>4 months), posing additional risks and costs. Neonatal MRI performed at term-age (without sedation) diminishes the risks and costs associated with later MRI under general anaesthesia and provides the opportunity to identify infants’ risk status early, enabling earlier and personalized treatment plans. This project aims to test the feasibility and use of neonatal MRI (at term-age) for 42 infants identified as high risk based on the cranial ultrasound or clinical grounds, making use of the learnings from the successful implementation of neonatal MRI protocols at Royal Brisbane Women’s Hospital.

Eligibility

Sex: Both males and femalesMax Age: 42 Weekss

Plain Language Summary

Simplified for easier understanding

Premature babies and others who experience difficult births are at higher risk of developmental problems as they grow up. Brain MRI scans can detect early signs of brain injury and growth problems that can't be seen on a standard ultrasound, helping doctors identify babies who might benefit from early support or therapy. This study tests the feasibility of performing neonatal brain MRI (without sedation, at around the baby's due date) at two North Queensland hospitals — Townsville University Hospital and Cairns Hospital — for babies identified as being at high risk. The goal is to see whether the program can be successfully implemented in a regional Australian context, following the model already established at Royal Brisbane Women's Hospital. Your baby may be eligible if they were born very preterm (before 32 weeks), have low birth weight (under 1500g), experienced a hypoxic event (such as birth asphyxia), or have had a significant brain bleed identified on an ultrasound. Babies with known chromosomal abnormalities, those who are medically unstable, or whose families cannot provide consent are not eligible. The study aims to extend specialised brain monitoring to babies in regional Queensland who would otherwise miss this assessment.

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Interventions

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)

Locations(2)

Townsville University Hospital - Douglas

QLD, Australia

Cairns Hospital - Cairns

QLD, Australia

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ACTRN12622001584729