School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy

NCT07770035 | Enrolling By Invitation

• 2 other identifiers: Inf_Sophie_2311024/FFP-P/12824(N) CHF
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

HIE; neonatal encephalopathy; neurodevelopment; cognitive outcome; MRI

Outcome Measures

Primary Outcomes (5)

• Intelligence Quotient

  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.

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

• Assessment of Exectuive Function

  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)

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

• Volumetric analysis of MRI brain

  Total and regional brain volumetric analysis

  Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1

• Connectivity analysis of MRI brain

  Analysis of brain connectivity using diffusion tensor data and fransctional anisotopy imaging.

  Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1

• MRI Machine Learning Model

  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.

  Visit 2 - 20 minute MRI scan, approximately 2-4 months after Visit 1

Secondary Outcomes (4)

• Behavioural Profile

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

• Incidence of additional school supports

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

• Socioeconomic Background

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

• Cognitively Stimulating Home Environment

  Visit 1 - Approx 1.5 hours, aged 5-12 years old

Study Arms (2)

Hypoxic Ischaemic Encephalopathy (Case)

Children aged 5-12 years old with HIE meeting study inclusion criteria

Age-Matched Control

Healthy controls aged 5-12 years old, now attending mainstream school, who did not have HIE or were not admitted to the neonatal unit within 12 hours of birth.

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Cases: Potential participants will be identified from seven previous studies conducted in Cork University Maternity Hospital (CUMH), between January 2013-December 2019. Over this period, term infants ≥36 weeks considered at significant risk of HIE were recruited prospectively to these studies as soon as possible after delivery. Clinical data, blood biomarkers, MRI and EEG recordings were collected and stored in the INFANT databank using unique study numbers. Controls: Children aged between 4-12 years of age, who are attending general paediatric outpatients' clinics at Cork University Hospital (CUH) will be selected as potential participants for the control group. Controls will be healthy children born at ≥ 36 weeks gestation now attending mainstream school who did not have a diagnosis of HIE at birth. To be eligible, they must not have been admitted to the neonatal unit in the first 12 hours after birth and have had a 5-minute Apgar score of ≥7.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Born at ≥ 36 weeks gestation
• Attending mainstream primary school without a specific developmental diagnosis
• 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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Cork, Ireland

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian H Walsh, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 18, 2026
• Study Start: March 9, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

IE (1)