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Clinical Trials in Ireland / NCT07880431
Enrolling by invitation Observational

Intelligent Physiological Monitoring to Predict Preterm Brain Injury

NCT07880431 · tracked via the Priya Life Science Ireland tracker
Sponsor
University College Cork
Phase
Observational
Started
2026-04-13
Last updated
2026-10-19

Condition(s) studied

Cerebral Palsy (CP)Intraventricular Hemorrhage NeonatalPeriventricular LeukomalaciaNeurodevelopmental Delay

Investigational drug(s) / intervention(s)

EEGNIRS

EEG: During the first 72 hours after birth

NIRS: During the first 72 hours after birth

Study summary

Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (\<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL) develop usually during the first few days after birth and are a strong predictor of CP. Development of IVH or PVL have been linked to hemodynamic instability. Artificial intelligence (AI) provides an opportunity to detect patterns from continuous physiological monitoring data that are associated with prematurity-related brain injury. A dataset of extremely preterm infants will be collated from previous INFANT Research Centre study cohorts. A separate but aligned anonymous dataset will be obtained from the University of Graz. Continuous physiological monitoring data will be analyzed with AI algorithms to identify infants with the highest risk of brain injury.

Eligibility

Sex
ALL
Min age
—
Max age
5 Days
Healthy volunteers
No
Inclusion Criteria: * Neonates with GA of 23 weeks 0 days to 31 weeks 6 days born between 01 JAN 2009 and 31 DEC 2021 and enrolled in any of the six previously collected INFANT study cohorts or in the University of Graz study. * Documented parental informed consent for the previously conducted study data to be used in the future for related research. Exclusion Criteria: * Congenital malformation or genetic syndrome. * Lack of parental consent for the original study data to be used for future related research.

Primary outcome measure(s)

  • Early brain injury or death — Within 36 weeks of gestation
    IVH, PVL or death
  • Cerebral palsy (CP) — At 3 years
    CP diagnosis

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 NCT07880431 on ClinicalTrials.gov ↗ ← All trials in Ireland