Intelligent Physiological Monitoring of Preterm Infants to Predict Brain Injury Associated With CP and With Confirmed CP in the First Days After Birth
| Registry | NCT07880431, acronym AI4NICU |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 413 (Estimated) |
| Sponsor | University College Cork (Other); collaborators: Cerebral Palsy Foundation, Science Foundation Ireland |
| Conditions | Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal, Periventricular Leukomalacia, Neurodevelopmental Delay |
| Interventions | EEG, NIRS (Diagnostic test) |
| Dates | start 2026-04-13, primary completion 2027-12-01 (estimated), completion 2029-10-01 (estimated), first posted 2026-10-19, last updated 2026-10-19 |
| Locations | 1 site in Ireland |
Related Papers Related Patents Related Grants Related Experts
All trials for Cerebral Palsy (CP) All trials for Intraventricular Hemorrhage Neonatal All trials of EEG All trials of NIRS
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Very Preterm Infants | Diagnostic Test: EEG; Diagnostic Test: NIRS | Very Preterm Infants that had early neuromonitoring |
Sex: All, ages: any to 5 Days
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University College Cork | Cork, Cork | Ireland |