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

Not Applicable

• Conditions: Preterm birth; Low birth weight; Severe intraventricular haemorrhage (Grade III-IV); Hypoxic event at birth; Brain injury in neonates; Reproductive Health and Childbirth - Complications of newborn; Neurological - Other neurological disorders

• Registration Number: ACTRN12622001584729
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-22
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 42

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).

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[3 months (primary timepoint)];The number of early referrals to services and intervention (primary outcomes) - assessed by audit of patient medical records[ 1 year corrected age (primary timepoint) ];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. [ 1 year corrected age (primary timepoint)]