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Clinical Trials in Ireland / NCT07770035
Enrolling by invitation Observational

School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy

NCT07770035 · tracked via the Priya Life Science Ireland tracker
Sponsor
University College Cork
Phase
Observational
Started
2024-03-09
Last updated
2026-08-18

Condition(s) studied

Hypoxic-Ischemic Encephalopathy

Study summary

Neonatal HIE increases the risk for cognitive impairments in childhood. Neonatal MRI brain scans are a strong predictor for outcome, however a normal scan has only a 35% sensitivity and 85% specificity for a normal outcome. This may be explained by variability in the brain's development over time in response to the initial insult.

This project will aim to develop a neonatal MRI machine learning algorithm that incorporates both initial injury and radiomic features associated with future brain development (based on school-age MRI) to predict school-age outcome. This will be achieved by conducting a case-control cohort study looking at School-age MRI and outcomes of children with a history of neonatal HIE.

Eligibility

Sex
ALL
Min age
5 Years
Max age
12 Years
Healthy volunteers
Accepted
Cases: Inclusion Criteria: * Known diagnosis of HIE of any grade and enrolled in one of seven studies carried out in CUMH and born between 01 JAN 2013 and 31 DEC 2020 * Documented parental informed consent for their study data to be used in the future for related research and for them to be contacted again. Exclusion Criteria: * Lack of parental consent for the original study and no permission to be contacted for future research. * Death prior to study initiation * Congenital malformation or genetic syndrome Controls: Inclusion Criteria: * Born at ≥ 36 weeks gestation * Attending mainstream primary school without a specific developmental diagnosis Exclusion Criteria: * Diagnosis of perinatal asphyxia or HIE at birth * Admission to the neonatal unit within 12 hours of birth * Attending a paediatric clinic for a developmental concern * Congenital malformation or genetic syndrome

Primary outcome measure(s)

  • Intelligence Quotient — Visit 1 - Approx 1.5 hours, aged 5-12 years old
    Kaufman Brief Intelligence Test Second Edition (KBIT-2) is a brief measure of verbal and nonverbal intelligence used with individuals aged from 4 to 90 years.
  • Assessment of Exectuive Function — Visit 1 - Approx 1.5 hours, aged 5-12 years old
    Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess the following domains: Visual Memory- Delayed Match to Sample (DMS) Working memory- Spatial Working Memory Task (SWM), Spatial Span Task (SSP), Digit Span Task (DGS) Attention/processing speed- Reaction Time Task (RTI), Rapid Visual Processing Task (RVP), Motor Screening Task (MOT) Inhibitory control- Stop Signal Task (SST)
  • Volumetric analysis of MRI brain — Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1
    Total and regional brain volumetric analysis
  • Connectivity analysis of MRI brain — Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1
    Analysis of brain connectivity using diffusion tensor data and fransctional anisotopy imaging.
  • MRI Machine Learning Model — Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1
    Using MRIs completed at school-age and neonatal data, extract radiomic features and ragions of interest (ROIs) to develop machine learning models to predict school-aged cognitive outcome.

Trial sites (1)

FacilityCityRegionStatus
University College Cork Cork Cork

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07770035 on ClinicalTrials.gov ↗ ← All trials in Ireland